NA 86-7434Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295217947), received between Dec 14, 2017 and Jul 14, 2021 — classified as 3 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE IS TO CAPTURE PATIENTS¿ PRIOR REVISIONS REPORTED IN (B)(4). THIS WAS THE SEVENTH REVISION FOR THIS PATIENT. PATIENT UNDERWENT A LEFT PRIMARY TOTAL KNEE REPLACEMENT (TKR) ON (B)(6) 2009. PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2018 ¿DUE TO TIBIAL PAIN.

  Patient problems: Pain

  MAUDE report 12168107 ↗
• InjuryDec 14, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THERE WAS A SURGICAL DELAY OF 1 HOUR.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7116613 ↗
• InjuryDec 14, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DER STATES THAT THEY REAMED THE FEMUR TO 22X115 PUT OUR TRIAL IN AND THE STEM ENGAGED AND FIT SNUG. WHEN PUTTING IN THE ACTUAL IMPLANT THE STEM JUST FELL RIGHT INTO THE FEMORAL CANAL, THEY CHECKED THE IMPLANT WITH A CALIPER AND IT WAS MEASURING AT 20MM. THEY ENDED UP OPENING A SECOND 22MM AND IT RESULTED IN THE SAME RESULTS. THEY FINISHED BY PUTTING IN A 24X115 AND IT FIT SNUG.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7116579 ↗