Mpact Acetabular System 01.32.6525Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030812385), received between Jul 27, 2017 and Dec 22, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS AND 9 MONTHS FROM PRIMARY THE PATIENT REPORTED PAIN, PERFORATION OF THE PELVIC WALL FROM ONE OF THE SCREW WAS IDENTIFIED. THE SCREW WAS IRRITATING THE PSOAS MUSCLE AND NERVE. IT IS UNKNOWN WHICH OF THE TWO SCREWS WAS PROTRUDING. SURGEON REVISED THE SCREWS, HEAD AND LINER. SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 23862959 ↗
• InjuryApr 6, 2022Migration; Migration

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT 8 MONTHS AFTER THE PRIMARY SURGERY REPORTING PAIN AND X-RAYS SHOWED A SCREW IN THE OBTURATOR FORAMEN. THE SURGEON PERFORMED A RIGHT HIP HEAD AND LINER CHANGE WITH SCREW REMOVAL (TWO-HOLES CUP). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14021289 ↗
• MalfunctionMay 24, 2019Fracture; Fracture

  DURING THE PRIMARY HIP SURGERY AND AFTER DRILLING A HOLE IN THE ACETABULUM FOR SCREW PLACEMENT, THE HEAD OF THE 25MM MPACT DOME SCREW BROKE OFF WHILE THE SURGEON WAS IMPLANTING IT INTO THE ACETABULUM. THE BROKEN SCREW FRAGMENT WAS RECOVERED BUT THE THREADED PORTION OF THE SCREW WAS LEFT IN THE ACETABULUM. THE SURGEON WAS ABLE TO SUCCESSFULLY PLACE A 15MM MPACT DOME SCREW INTO THE SECOND HOLE OF THE MPACT 2-HOLE CUP AND THE CUP WAS WELL FIXATED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8640291 ↗
• MalfunctionJul 27, 2017Packaging Problem; Packaging Problem

  SMALL DEBRIS CAME OFF SCREW. THIS WAS NOTICED WHEN THE SCREW WAS TAKEN FROM IT'S STERILE PACKAGING. A NEW 25MM CANCELLOUS SCREW WAS OPENED TO BE USED FOR THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6746790 ↗