RECLAIM 2975-28-105Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295156253), received between Sep 6, 2018 and Dec 16, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2020Peeled/Delaminated; Peeled/Delaminated

  RECLAIM HIP REVISION (B)(6) 2020. DURING REAMING OF THE PROXIMAL BODY THE LOOSE PARTS OF THE COLOURED RINGS WERE NOTICED. THEY USED EXTRA PULSE LAVAGE TO DECREASE THE RISK OF PARTS IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 11024762 ↗
• MalfunctionSep 6, 2018Break; Corroded; Material Discolored; Appropriate Device Problem Term/Code Not Available; Break; Corroded; Material Discolored; Appropriate Device Problem Term/Code Not Available

  AFTER RECEIVING 2 COMPLAINTS ABOUT A HIP KIT, ORTHOKIT MANAGER CHECKED THE BUILD 5 IN THE WAREHOUSE, AND SAW RUST ON ALMOST EVERY PART OF THE KIT. FOR SOME PARTS IT'S ALSO MISSING COLOR CODES (USUALLY RED, YELLOW, GREEN, BLUE). THIS KIT WENT TO A CUSTOMER IN (B)(6) 2016 AND WAS NEW AT THE TIME. IT WAS CHECKED WHEN IT CAME BACK IN 2016 AND WAS LET IN STORAGE SINCE THEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7850205 ↗