Mpact Acetabular System 01.32.6540Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030812415), received between Jul 20, 2017 and Oct 18, 2019 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2018. POST-OP X-RAYS WERE TAKEN AND IT WAS OBSERVED THAT THE PATIENT HAD INTERNAL BLEEDING. ON (B)(6) 2019, THE SURGEON REMOVED 2 IMPACT DOME SCREW 40MM SCREWS AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9208358 ↗
• MalfunctionSep 6, 2018Break; Break

  DURING FINAL TIGHTENING A SCREW HEAD BROKE OFF. THE SURGEON REMOVED THE SCREW HEAD, BUT THE THREADS REMAINED IN THE PATIENT. THE SURGEON USED A SECONDARY SCREW COMPLETING SUCCESSFULLY THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7850473 ↗
• MalfunctionMar 1, 2018Break; Break

  DURING SURGERY THE SCREW HEAD BROKE OFF. THE SCREW REMAINS IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. INSTRUMENT USED TO CREATE THE HOLE: (B)(4) DRILL GUIDE; (B)(4) DRILL SHAFT; (B)(4) DRILL BIT. THE HOLE WAS PERFORMED WITH THE CORRECT INCLINATION. THE SCREW WAS INSERTED WITH THE REF (B)(4) (HANDLE) AND WITH THE REF (B)(4) (DRIVER).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7306126 ↗
• MalfunctionDec 22, 2017Break; Break

  DURING SURGERY WHEN THE SURGEON WAS DRILLING FOR A SCREW THE DRILL BIT BROKE. THE SURGEON USED A SECONDARY DRILL BIT. THE SECOND DRILL BIT ALSO BROKE. ALL FRAGMENTS FROM BOTH BITS WERE RECOVERED. THE SURGEON USED A TERTIARY DRILL BIT TO COMPLETE THE SURGERY. THEN, WHILE IMPLANTING THE SCREW, THE SCREW HUB BROKE OFF. THE THREADS REMAIN IN THE PATIENT. THE SURGEON USED A SECONDARY SCREW TO SECURE THE CUP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7142940 ↗
• MalfunctionDec 14, 2017Material Deformation; Material Deformation

  WHEN THE SURGEON WAS IMPLANTING THE SCREW, THE SCREW BENT. THE SURGEON USED A SECONDARY SCREW TO COMPLETE THE SURGERY. THERE WAS A 10 MINUTE DELAY IN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7117208 ↗
• InjuryJul 20, 2017Break; Break

  WHEN THE SURGEON WAS IMPLANTING THE SCREW, THE HEAD OF THE SCREW BROKE OFF. THE SURGEON RECOVERED THE SCREW HEAD. THE SHAFT OF THE SCREW REMAINS IMPLANTED INTO THE PATIENT. THERE WAS APPROXIMATELY A 5 MINUTE DELAY IN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 6727733 ↗