Mpact Acetabular System 01.32.6535Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630030812408), received between Apr 4, 2018 and Jan 30, 2020 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER 1 YEAR AND 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9646641 ↗
• MalfunctionOct 9, 2019Material Deformation; Material Deformation

  DURING THE PRIMARY HIP SURGERY, WHILE THE SURGEON WAS DRILLING A HOLE FOR THE SCREW INTO THE ACETABULUM, THE DRILL BIT BROKE. ALSO WHILE SCREWING INTO THE ACETABULUM, A SCREW WARPED. THE SURGEON HAD A BACK-UP DRILL BIT AND A SCREW AND COMPLETED THE CASE BY USING THEM. THERE WAS NO DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9171456 ↗
• MalfunctionOct 8, 2019Loose or Intermittent Connection

  DURING SCREW IMPLANTATION THE FIRST ONE WENT OVER THE HOLE AND THE SECOND ONE REMAINED NOT TOTALLY SCREWED IN THE CUP HOLE. THE SURGEON DECIDED TO REMOVE THE SCREWS AND TO LEFT THE CUP IN PLACE WITHOUT SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9165881 ↗
• InjuryJul 19, 2019Fracture; Fracture

  ONE OF THE SCREW HEAD SHEERED OF OFF DURING THE INSERTION INTO THE ACETABULUM. NO IMPINGEMENT OF THE BROKEN SCREW TO THE LINER, SO IT WAS LEFT IN PLACE AND LINER IMPLANTED. IT IS UNKNOWN WHICH OF THE 2 IMPLANTED SCREWS IS THE BROKEN ONE AS BOTH WERE OPENED AT THE SAME TIME AND BOTH ARE OF THE SAME LENGTH.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8806110 ↗
• MalfunctionMar 29, 2019Material Fragmentation; Material Fragmentation

  DURING THE PRIMARY HIP SURGERY AND WHILE IMPLANTING THE 35MM IMPACT DOME SCREW, THE HEAD OF THE SCREW BROKE OFF. THE SURGEON STATED THE PATIENT HAD VERY HARD BONE AND THAT HE MAY HAVE NOT DRILLED DEEP ENOUGH PRIOR TO IMPLANTING THE SCREW. THE SURGEON CHOSE TO LEAVE THE BROKEN SCREW IN PLACE AND THERE WAS NO INTERFERENCE BETWEEN THE SCREW AND THE LINER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8464668 ↗
• MalfunctionSep 28, 2018Break

  DURING SURGERY, WHEN THE SURGEON HAS DRILLED THE SECOND SCREW (MEASURED ACCORDING TO PROTOCOL) AND HE HAS INSERTED IT, AS THE SCREW HEAD ENGAGED THE ACETABULAR SHELL, THE HEAD OF THE SCREW BROKE OFF, LEAVING THE THREADED PORTION OF THE SCREW IN THE ACETABULUM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7918473 ↗
• MalfunctionApr 4, 2018Break; Break

  DURING THE SCREW FINAL TIGHTENING, THE IMPLANT HEAD SHEARED OFF. THE SHAFT OF THE SCREW REMAINED IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7395351 ↗