NA 1294-35-160Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295025993), received between Jan 20, 2021 and Aug 30, 2022 — 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.

• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY AND ASEPTIC LOOSENING OF FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. ORIGINAL IMPLANT DATE UNKNOWN. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15322136 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THE PATIENT HAD A LEFT CEMENTED TOTAL KNEE ARTHROPLASTY TO ADDRESS PRIMARY END-STAGE LEFT KNEE, SEVERE WITH SEVERE VARUS DEFORMITY AND MEDIAL TIBIAL BONE LOSS. CONTRACTURES WERE NOTED DURING THE PROCEDURE. ON (B)(6) 2017, THE PATIENT HAD A REVISION LEFT TOTAL KNEE TIBIAL COMPONENTS TO ADDRESS INFECTED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO CONTIGUOUS INFECTION AND BREAKDOWN OF LEFT TOTAL KNEE ARTHROPLASTY WOUND. ONLY THE INSERT WAS REVISED. ON (B)(6) 2017, THE PATIENT HAD A LEFT ABOVE THE KNEE AMPUTATION TO ADDRESS CHRONIC RECALCITRANT LEFT TOTAL KNEE ARTHROPLASTY INFECTION. GROSS PUS WAS FOUND WITHIN THE KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Perforation of Vessels; Unspecified Tissue Injury

  MAUDE report 11413034 ↗
• InjuryJan 20, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT AN UNKNOWN INTERFACE. CEMENT MANUFACTURER WAS NOT INDICATED/UNKNOWN. IT WAS REPLACED WITH AN MBT TRAY AND STEM. DOI: NOT INDICATED/UNKNOWN, DOR: (B)(6) 2021, UNKNOWN KNEE AFFECTED SIDE.

  Patient problems: Insufficient Information

  MAUDE report 11203126 ↗