Mpact 3D Metal 01.38.050DHRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030812583), received between Jan 10, 2020 and Apr 21, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 18, 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.

• InjuryApr 21, 2023Malposition of Device; Malposition of Device

  DURING THE IMPACTION OF THE LINER INTO THE TWO-HOLE CUP, IT WAS NOT POSSIBLE TO PLACE THE ACETABULAR SHELL IN THE CORRECT POSITION. IT WAS PLACED TOO MUCH ON THE PELVIC SIDE. THE SURGERY WAS COMPLETED SUCCESSFULLY BY USING A MULTI-HOLE CUP AND 4 SCREWS. DELAY TIME 40MIN AND THE TOTAL TIME 170MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16783224 ↗
• InjuryJun 2, 2022Loosening of Implant Not Related to Bone-Ingrowth

  AT 2 MONTHS FROM PRIMARY, REVISION SURGERY FOR ACETABULAR SHELL LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY. ALL ACETABULAR COMPONENTS AND HEAD REVISED SUCCESSFULLY. THE PATIENT START TO HAD PAIN SINCE 1 MONTH AFTER PRIMARY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14573984 ↗
• InjuryApr 5, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND IMPLANTED AN ANTIBIOTIC SPACER 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14012351 ↗
• MalfunctionJan 10, 2020Positioning Problem

  DURING THE PRIMARY HIP SURGERY, THE SURGEON ATTEMPTED TO INSERT AN IMPACT FLAT LINER HC 32/D INTO THE IMPACT 3D METAL SHELL TWO HOLE 50MM, BUT IT WOULD NOT SEAT. THE SURGEON EXPLANTED THE LINER AND ATTEMPTED TO INSERT A DIFFERENT IMPACT FLAT LINER HC 32/D BUT IT WOULD NOT SEAT INTO THE CUP. THE SURGEON EXPLANTED THE LINER, CUP AND SCREWS AND REAMED THE ACETABULUM UP ONE SIZE. HE THEN IMPLANTED AN IMPACT 3D METAL SHELL TWO HOLE 52MM, MPACT FLAT LINER HC 36/E AND SCREWS WITH NO FURTHER ISSUES. THERE WAS A 25-MINUTE DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SALES REPRESENTATIVE REPORTED THAT HE WAS ABLE TO COUPLE THE INSERT AND THE CUP (AFTER RECEIVING THE CUP AND THE LINER WERE COUPLED). PROBABLY SOMETHING BLOCKED THE LINER DURING THE SURGERY TO SEAT CORRECTLY IN THE CUP.

  Patient problems: Failure of Implant

  MAUDE report 9575259 ↗