RECLAIM 2975-00-645Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295156031), received between Dec 27, 2024 and Dec 27, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Structural Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2024Structural Problem; Structural Problem

  IT WAS REPORTED THAT THIS CASE WAS A HEMI HIP WITH REMOVAL OF A FEMORAL NAIL AND PLACEMENT OF A RECLAIM REVISION STEM AND ENDO HEAD. THE NAIL WAS REMOVED WITHOUT ISSUE AND THE FEMUR WAS PROPPED FOR AN 18X140 RECLAIM DISTAL TAPERED STEM AND 85X20MM PROXIMAL BODY. WHILE USING THE ASSEMBLY TOOLS, THE SURGEON TIGHTENED WITH THE TORQUE WRENCH UNTIL THEY HEARD THE SOUND OF THE TENSILE BAR BREAKING BUT WHEN THEY DISASSEMBLED THE TORQUE WRENCH SETUP IT WAS DISCOVERED THAT THE TENSILE BAR DID NOT BREAK. THEY HAD AN ADDITIONAL TENSILE BAR SO THEY LOADED THAT INTO THE ASSEMBLY TORQUE WRENCH AND APPLIED THE WRENCH TO THE STEM AND DISTAL BODY A SECOND TIME. THEY HEARD THE TENSILE BREAK AND THEN TOOK THE ASSEMBLY WRENCH APART AND VISUALLY CONFIRMED THAT THE TENSILE BAR HAD BROKEN. AFTER THAT, THE LOCKING BOLT WAS IMPLANTED AND TORQUED AND THE CASE WAS COMPLETED. THE DIFFICULTIES WITH THE FIRST TENSILE BAR ADDED APPROXIMATELY TEN MINUTES TO THE CASE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026299 ↗