6 results

• Hintermann Ankle Replacement Problems Draw New FDA Warning Over ‘Higher-Than-Expected’ Failure Rates

  June 11, 2026

  Michael Adams

  Federal regulators are advising surgeons and patients to consider alternatives to the Hintermann H3 Total Ankle Replacement system after post-approval data showed failure rates far exceeding those reported during premarket testing.

• Hintermann H3 Ankle Replacement Failures Occur in 31.8% of Patients at 10 Years, FDA Warns

  November 4, 2025

  Michael Adams

  New post-market data reveals that Hintermann H3 ankle replacements are failing at rates more than 15 percentage points higher than first reported, according to findings released after federal regulators issued a safety warning early last year.

• Hintermann Series H3 Total Ankle Replacement Failure Warning Issued by FDA

  March 4, 2024

  Irvin Jackson

  The FDA is warning that Hintermann Series H3 ankle replacement systems have a higher rate of failures than previously believed, leading to the need for additional surgery for more than quarter of recipients.

• Exactech Recall Letters May Never Reach Some Knee, Ankle Replacement Recipients

  May 18, 2022

  Irvin Jackson

  Recipients of some recalled Exactech knee and ankle implants will receive letters warning them their implants may be prone to premature wear and failure.

• Exactech Knee Recall Issued for Optetrak, Optetrak Logic and Truliant Implants That May Fail

  February 14, 2022

  Irvin Jackson

  An Exactech Optetrak knee recall impacts 147,732 implants since 2004, which may degrade and wear out prematurely. Failure rates may be 3 to 7 times higher than other total knee replacement systems

• Stryker STAR Ankle Replacement Fracture Problems Result in Warning To Monitor For Symptoms

  November 13, 2019

  Russell Maas

  Patients and doctors are being warned about a risk of problems with Stryker STAR Ankle Replacements, which may fracture or...