Stryker Knee Replacement Cutting Guide Lawsuit
A recall has been issued for Stryker ShapeMatch Cutting Guides, which were used with Stryker Triathlon knee replacements to help surgeons plan out and mark bones before surgery. A number of former knee replacement patients have experienced problems where their implant was misaligned due to the defective cutting guides.
STRYKER KNEE REPLACEMENT LAWSUIT STATUS Product liability lawyers are reviewing potential Stryker ShapeMatch recall lawsuits for individuals who have experienced problems following surgery where a Stryker Triathalon knee replacement was used, such as:
- Pain and Discomfort
- Joint Instability
- Limited Mobility
- Revision Surgery to Remove and Replace the Artificial Knee
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OVERVIEW: The Stryker ShapeMatch Cutting Guide was sold with the company’s Triathalon Total Knee System to assist in the placement and marking of bone before cutting.
The single-use, disposable guides are created from plans submitted by the surgeon after taking 3D imaging from an MRI or CT scan to determine the appropriate placements for a specific patient. The surgeon creates the plans, submits them through a web app and reviews the information before approval. However, due to problems with the Stryker ShapeMatch software, many of the cutting guides provided by the manufacturer did not match the appropriate specifications.
As a result of using a defective ShapeMatch Cutting Guide, patients could experience problems with their Stryker Triathlon knee replacement that result in severe pain, joint instability and the need for revision surgery to remove or replace the misaligned knee implant.
STRYKER KNEE RECALL Stryker stopped selling the ShapeMatch Cutting Guide in November 2012. A Product Notification was sent to all hospitals and medical providers using the system in January 2013, informing them of the problem and risk mitigation factors.
It appears that the FDA was not informed of the Stryker knee problems or of the many complaints received by the manufacturer. The FDA issued a warning letter to Stryker in March, claiming that the company had failed to notify the agency of a medical device recall, but the letter did not mention the ShapeMatch Cutting Guides by name.
In April 2013, a Stryker ShapeMatch Cutting Guide recall was issued and categorized by the FDA as a Class I recall, because of the substantial likelihood for serious injury. At that time, the FDA had received a total of 44 reports of ShapeMatch Cutting Guide problems, including 41 malfunctions and three injuries.
According to allegations raised in Stryker knee replacement lawsuits filed over the ShapeMatch recall, the manufacturer:
- Failed to properly report problems with the Stryker Triathalon knee replacement
- Failed to conduct an investigation and analysis of the knee replacement failures
- Failed to report any and all information regarding corrections
- Failed to adequately warn surgeons and hospitals about the risk of problems
- Failed to conduct necessary design validation
As a result of problems following Stryker knee replacement surgery, product liability lawyers are reviewing potential claims nationwide. Financial compensation may be available through a Stryker ShapeMatch recall lawsuit as a result of the manufacturers actions, in which they appear to have placed their desire for profits before patient safety.
SandraJanuary 13, 2023 at 12:26 pm
I had the Mako Stryker robotic left knee replacement in July 2020. At each of the post op appointments I would tell my Dr that it didn't feel right. He would say it was fine. Now, I am having the same issues but with pain. It aches all the time. I had surgery to have no pain......this isn't fun.
RebeccaSeptember 1, 2022 at 1:33 pm
I had a knee replacement on 2-13-2018 a huge knee wrong size it is Stryker knee it hurts it gives out and it makes alot of noise and pops out when I quit down. I have fallen many times for it given out. I have a CD they did for me to see if I have recall parts from my surgery. My knee has always given out since surgery. Please check into this. Thank you Rebecca Freeman
MichaelJuly 1, 2022 at 12:22 pm
Had a 7 triathlon knee implant in October 2019 that became infected . Had to use pic line for approximately 3 months. Leg doesn’t bend after 3 revisions. Coming up on 6th surgery. Leg gives out . Constant pain. Stryker states no recalls but surgery notes leading into 2nd surgery, surgeon clearly states revision is necessary due to infection. Any advise.
FloydOctober 4, 2021 at 4:52 pm
Had a tkr on my left knee , shape match cutting guide was used in my 2018 Surgery and to wide of a cut was made , it loosened and got infected, on a pain scale it's a 10 all the time and ended up having to get antibiotics through a pic line , to my leg, in my arm for 8 weeks or so , after got infection under control , had to get revision surgery , still can't straighten leg , can slightly b[Show More]Had a tkr on my left knee , shape match cutting guide was used in my 2018 Surgery and to wide of a cut was made , it loosened and got infected, on a pain scale it's a 10 all the time and ended up having to get antibiotics through a pic line , to my leg, in my arm for 8 weeks or so , after got infection under control , had to get revision surgery , still can't straighten leg , can slightly bend leg , one leg is longer than the other for some reason , revision surgery didn't help my leg so can someone help me please!!!!!
StevenOctober 7, 2020 at 9:35 pm
I had a stryker trialthon knee replacement surgy it losened mlm up and needed a revision surgeryg
GregoryDecember 17, 2019 at 9:43 pm
I had a Stryker knee implant placed into my. Left knee. It immediately started hyperextending and popping out of the joint. The knee had a revision The problem began occurring directly after surgery In all my left knee has been operated on over 13 times; incurred four infections requiring iv antibiotics; tissue and bone had to be removed. I believe the knee was replaced 5 times in a 7 year period[Show More]I had a Stryker knee implant placed into my. Left knee. It immediately started hyperextending and popping out of the joint. The knee had a revision The problem began occurring directly after surgery In all my left knee has been operated on over 13 times; incurred four infections requiring iv antibiotics; tissue and bone had to be removed. I believe the knee was replaced 5 times in a 7 year period. I have incurred many costs from all of the procedures as well as a multitude of pain from having to undergo all of these procedures This is but a small snapshot of the experience I went through and am still going through If there is anything that could do for me or my family please let me know Thanks GREGORY
SandraNovember 7, 2017 at 9:08 pm
The Stryker rep never reported adverse events Dr Levitt in miami did many revisions,wrote the surgical protocol for the procedure yet never submitted knee revisions or poly changes
SandySeptember 11, 2015 at 12:10 am
The stryker rep jack jieafa was in my surgeries where shape match ( otismed) guides were used yet he never put in an adverse event rwport when my knee was revised hurting all of people I have the documents and the adverse event numbers I put in
DeborahJuly 30, 2014 at 11:21 pm
Bi-lateral Surgery was done 3/25/2013, and @ follow-up PM August 6, 2013, I told my doctor my left knee was not right. When I rode my bike (stationary) my left foot was crooked and always pointed to the left and I cannot be straightened out. My hips, and lower back, are constantly in pain. When I finish riding my bike, my left knee swells up more than usual. The left knee is still swollen from the[Show More]Bi-lateral Surgery was done 3/25/2013, and @ follow-up PM August 6, 2013, I told my doctor my left knee was not right. When I rode my bike (stationary) my left foot was crooked and always pointed to the left and I cannot be straightened out. My hips, and lower back, are constantly in pain. When I finish riding my bike, my left knee swells up more than usual. The left knee is still swollen from the knee replacement surgery. Just before knee surgery, I found out I had rheumatoid arthritis. When I walk my left side seems shorter than the right, and I limp on my left side. My balance is off, especially when I lean on my left side.
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