Mpact Acetabular System 01.32.158MHRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030810909), received between Jul 4, 2018 and Jul 18, 2025 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IN (B)(6) 2025 THE PATIENT UNDERWENT THA. ON THE (B)(6), THE PATIENT UNDERWENT REVISION SURGERY DUE TO AN ACETABULAR FRACTURE CAUSED BY TRAUMA. NO MDR SENT AS IT WAS A TRAUMATIC EVENT. CURRENTLY, ON THE (B)(6), THE PATIENT UNDERWENT REVISION DUE TO SUSPECTED INFECTION. THE SURGEON REMOVED THE HEAD AND LINER AND PERFORMED A WASHOUT. ALSO, THE SURGEON TESTED THE CUP STABILITY AND FOUND IT MOBILIZED. THE SURGEON THEN PROCEEDED WITH THE REVISION OF THE CUP TOO WITH A 62 MPACT TWO-HOLES CUP. SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection; Septic loosening

  MAUDE report 22541818 ↗
• InjuryJul 21, 2021Migration or Expulsion of Device; Appropriate Device Problem Term/Code Not Available

  14 DAYS AFTER THE PRIMARY THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND ON THE LEFT SIDE IT WAS OBSERVED THAT THE CUP HAD MIGRATED AND THE CAUSE OF THE CUP MIGRATION IS UNKNOWN. THE SURGEON REVISED THE CUP AND LINER WITH COMPETITOR COMPONENTS ADDING AN AUGMENT AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12201464 ↗
• InjuryApr 29, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED FOLLOWING CUP LOOSENING 1 YEAR AND 4 MONTHS AFTER PRIMARY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11743642 ↗
• InjuryNov 11, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP. THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD, AND LINER 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10821842 ↗
• MalfunctionJan 25, 2019Device Contamination with Chemical or Other Material

  DURING THE PRIMARY HIP SURGERY AND UPON OPENING THE CUP PACKAGING, IT WAS DISCOVERED THAT THERE WAS FOREIGN DEBRIS INSIDE THE PACKAGING. THERE WAS A 10 MINUTE DELAY IN THE CASE WHILE THE AGENT CHECKED HIS INVENTORY TO SEE IF THERE WAS ANOTHER CUP AVAILABLE. NO OTHER CUP WAS AVAILABLE SO THE SURGEON CLEANED THE DEBRIS OFF OF THE CUP AND IMPLANTED IT INTO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8277371 ↗
• MalfunctionJul 4, 2018Biofilm coating in Device

  THE NURSE FOUND SOME COATING PIECES IN THE CUP INNER PACKAGING. THE SURGEON USED A BACK-UP IMPLANT TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7662369 ↗