NA 1294-56-121Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295026662), received between Nov 30, 2018 and May 1, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIBIAL COMPONENTS WERE REVISED FOR LOOSENING SECONDARY TO FRACTURE. TIBIA WAS LOOSE AT BONE TO CEMENT INTERFACE. CEMENT USED WAS FROM COMPETITOR BRAND. NO X-RAYS AVAILABLE. ALL KNOWN INFORMATION DISCLOSED. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 25058674 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIBIAL COMPONENTS WERE REVISED FOR LOOSENING SECONDARY TO FRACTURE. TIBIA WAS LOOSE AT BONE TO CEMENT INTERFACE. CEMENT USED WAS FROM COMPETITOR BRAND. NO X-RAYS AVAILABLE. ALL KNOWN INFORMATION DISCLOSED. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 25058660 ↗
• InjuryMay 14, 2025Migration; Migration

  IT WAS REPORTED THAT THERE WAS REVISION OF TIBIAL CONSTRUCT AS THERE WAS NO IN-GROWTH BETWEEN THE SLEEVE AND BONE AND TIBIAL STEM WAS IMPINGING ON THE TIBIAL INTRAMEDULLARY CORTEX. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020. DOE: (B)(6) 2025. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22018320 ↗
• MalfunctionNov 30, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHEN THE NURSE OPENED THE PACKAGE AND GAVE THE WEDGE TO THE TECH, THE SURGEON SAW IT AND IT HAD A POWDERY SUBSTANCE ON THE IMPLANT AND THEN A NEW WEDGE WAS OPENED.

  Patient problems: Not Applicable

  MAUDE report 8120037 ↗