Mpact Acetabular System 01.32.152SHRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030810817), received between Dec 12, 2018 and May 9, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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.

• InjuryMay 9, 2023Failure to Osseointegrate; Failure to Osseointegrate

  REVISION SURGERY AT ABOUT 2 MONTHS POST PRIMARY FOLLOWING SHELL MOBILIZATION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16893409 ↗
• InjuryFeb 12, 2021Malposition of Device; Malposition of Device

  THE PATIENT CAME IN REPORTING PAIN DUE TO CUP IMPINGEMENT. THE SURGEON REVISED THE CUP AND LINER TO A COMPETITOR CUP AND LINER 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGERY WAS COMPLETED SUCCESSFULLY. THE REASON THE PATIENT HAD A CUP IMPINGEMENT IS BECAUSE DURING THE PRIMARY SURGERY, THE CUP WAS MISPLACED AND UNDERSIZED/OVER-REAMED IN COMBINATION WITH THE PATIENT HAVING A SPINAL ISSUE THAT MAKES THE ROM CHALLENGING TO ACCESS UNDER ANESTHESIA.

  Patient problems: Failure of Implant; Pain

  MAUDE report 11321462 ↗
• InjuryMay 2, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 13 DAYS AFTER THE PREVIOUS REVISION (PERFORMED WASHOUT AND HEAD REVISION ALSO DUE TO AN INFECTION, MDR 2019-00290) DUE TO AN INFECTION (THE PATHOGEN HAS BEEN IDENTIFIED AS STAPHYLOCOCCUS). THE SURGEON PERFORMED A WASHOUT AND REVISED THE STEM, HEAD, LINER, AND CUP. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PRIMARY CASE WAS PERFORMED ON (B)(6) 2019.

  Patient problems: Unspecified Infection

  MAUDE report 8573535 ↗
• InjuryDec 12, 2018Fracture

  FROM THE EARLY POST-OP X-RAYS, THE SURGEON DETECTED AN ACETABULUM FRACTURE. THE PATIENT WILL BE NON-WEIGHT BEARING FOR 6 WEEKS. THE SURGEON PLANS TO FOLLOW UP ON THE FRACTURE IN 6 WEEKS TO DETERMINE IF IT HAS HEALED PROPERLY. THE SURGEON DOES NOT FEEL THAT A REVISION WILL BE NECESSARY.

  Patient problems: Bone Fracture(s)

  MAUDE report 8155016 ↗