PROFIX 71512478Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556034163), received between Feb 7, 2025 and Jan 5, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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 16, 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.

• MalfunctionJan 5, 2026Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE PRO MALLET RPLCMNT HD WAS FAULTY. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955930 ↗
• MalfunctionOct 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHILE USING THE METAL SIDE OF ONE (1) PRO MALLET RPLCMNT HD THE PLASTIC END BROKE OFF. THE BROKEN PIECE FELL ON THE FLOOR AND NOT IN THE PATIENT WOUND. NO FRAGMENTS IN THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23229324 ↗
• MalfunctionFeb 7, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THR SURGERY, UPON IMPACTION OF THE FEMORAL RASPS, THE PLASTIC PART OF ONE (1) PRO MALLET RPLCMNT HD FRACTURED AND CAME LOOSE FROM THE HANDLE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21340011 ↗