NA 1294-35-425Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295026051), received between Oct 31, 2019 and Apr 23, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).

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 18, 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.

• InjuryApr 23, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: TIBIAL TRAY LOOSE AND PAIN. AT REVISION, THE TIBIAL INSERT SHOWED MINOR YELLOWING.

  Patient problems: Pain

  MAUDE report 19168951 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION AND LOOSENING OF THE FEMORAL & TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. REMOVAL OF ALL IMPLANTS DUE TO CEMENT COULDN'T SEE MOST NUMBERS. ONLY ABLE TO OBTAIN THE NUMBERS FROM FEMORAL STEM, TC3 RP INSERT AND THE THICK TRAY. ALL OTHER PARTS WERE COVERED BY CEMENT. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2015. DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12517247 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING, INSTABILITY, DISLOCATED POLYETHYLENE, FOOTDROP AND EXTENSOR MECHANISM COMPROMISE. THE SURGEON NOTED THE POLYETHYLENE INSERT WAS COMPLETELY DISLOCATED. THE PATIENT WAS IMPLANTED WITH DEPUY KNEE SYSTEM AND COMPETITOR¿S CEMENT. THERE WERE NO COMPLICATIONS REPORTED WITH THE PROCEDURE. DOI: (B)(6) 2015 (PATELLAR AND FEMORAL COMPONENTS). DOI: (B)(6) 2017 (TIBIAL TRAY, INSERT AND BONE CEMENT). DOR: (B)(6) 2017 (LT KNEE).

  Patient problems: No Code Available

  MAUDE report 9260700 ↗