Hip Instruments 01.32.10.1154Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040753685), received between Apr 11, 2019 and Apr 11, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 16, 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.

• MalfunctionApr 11, 2019Material Fragmentation; Material Fragmentation

  DURING PRIMARY HIP SURGERY, THE 54MM IMPACTION PLATE BROKE, DURING IMPACTION, IN THE CONNECTION BETWEEN CENTRAL PIVOT AND LOCKING DISC, CAUSING THE SEPARATION OF THE PLASTIC BOTTOM FROM THE METAL PLATE. NO FRAGMENTS FELL INTO THE PATIENT'S WOUND AND THERE WAS NO DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8503590 ↗