Mpact Acetabular System 01.32.6520Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030812378), received between Feb 9, 2018 and Oct 4, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2019Difficult to Insert; Activation, Positioning or Separation Problem

  THE SURGEON WAS NOT ABLE TO INSERT COMPLETELY 2 CANCELLOUS BONE SCREWS OF THE SAME REF. AND LOT INTO THE PATIENT'S ACETABULUM. BOTH SCREWS BLOCKED 5 MM BEFORE THE FINAL SEAT. A NEW DRILLING WAS PERFORMED, BUT THE SURGEON WAS NOT ABLE TO INSERT THE SCREWS COMPLETELY. FINALLY HE WAS ABLE TO INSERT 1 CANCELLOUS BONE SCREW BY IMPACTING IT WITH THE HAMMER. AT THAT TIME ACETABULAR CUP SEEMED TO BE WELL FIXED, SO THE SURGEON DECIDED TO DON'T INSERT THE SECOND SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY BUT WITH 20 MINUTES OF DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9155336 ↗
• InjuryDec 12, 2018Malposition of Device; Malposition of Device

  2 SCREWS WERE USED FOR ADDITIONAL FIXATION OF MPACT 2 HOLE SHELL. DURING THE SECOND SCREW INSERTION WITH REF 03.32.6525, IT WAS HARD TO INSERT EVEN THOUGH DRILL HOLE PREPARATION WAS COMPLETELY FINISHED (COMPETITOR'S DRILL GUIDE USED). FINALLY, THE SURGEON WAS ABLE TO INSERT THE SCREW AND FINISHED THE SURGERY. AFTER THAT, HE CONFIRMED THAT THE ALIGNMENT OF MPACT SHELL WAS NOT APPROPRIATE IN COMPARISON WITH PLANNING IN THE XRAY, SO THE REVISION SURGERY WAS PERFORMED IMMEDIATELY. MPACT SHELL AND BOTH SCREWS WERE USED AGAIN; ONLY MECTACER LINER WAS REPLACED. PATIENT'S BONE QUALITY: "NO" REMARKABLE.

  Patient problems: No Code Available

  MAUDE report 8155017 ↗
• MalfunctionFeb 9, 2018Device Issue; Device Issue

  THE SURGEON HAD DIFFICULTY PLACING THE CANCELLOUS BONE SCREW Ø6.5 L20 (THE SCREW THREAD WAS DAMAGED DURING SURGERY). THE SURGEON USED A CANCELLOUS BONE SCREW Ø6.5 L15 TO COMPLETE THE SURGERY.

  Patient problems: No Information

  MAUDE report 7259381 ↗