Mpact Acetabular System 01.32.6530Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030812392), received between Apr 10, 2018 and Sep 5, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 5, 2019Break; Break

  DURING THE PRIMARY HIP SURGERY, AND WHILE THE SURGEON WAS MANUALLY INSERTING THE SCREW INTO THE ACETABULUM, THE SCREW HEAD SHEARED OFF. THE SHAFT OF THE SCREW WAS LEFT INSIDE OF THE PATIENT'S ACETABULUM AND THE SCREW HEAD WAS RECOVERED. THERE WAS NO DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8964023 ↗
• MalfunctionAug 9, 2019Material Fragmentation; Material Fragmentation

  WHILE THE SURGEON WAS SCREWING ONE OF THE TWO IMPLANTED SCREWS, THE HEAD OF THE SCREW BROKE AND REMAINED ON THE SCREWDRIVER. THE THREADED BODY REMAINED IMPLANTED (IN THE CORRECT POSITION) IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8878374 ↗
• MalfunctionOct 8, 2018Break; Break

  DURING SCREW TIGHTENING, THE SCREW HEAD SNAPPED OFF. THE SURGEON USED THE APPROPRIATE MPACT SCREWDRIVER TO INTRODUCE AND TIGHTEN THE SCREW. THE BROKEN SCREW BODY WAS LEFT IN SITU. THE SURGERY WAS ANYWAY COMPLETED SUCCESSFULLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7943004 ↗
• MalfunctionApr 10, 2018Break; Break

  WHILE SCREWING IN THE BONE SCREW THE HEAD SHEARED OFF. THE SURGEON WAS ABLE TO RECOVER THE HEAD OF THE SCREW. THE SHAFT REMAINS IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 7412275 ↗