Mpact 3D Metal 01.38.054DHRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030812606), received between Jul 15, 2019 and May 29, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (3 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 18, 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.

• InjuryMay 29, 2026Osseointegration Problem

  AT ABOUT 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING MILD PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THERE WAS NO TRAUMA OR INFECTION INDICATED. AFTER AN ORTHOPEDIC SURGEON OBSERVATION, THE CUP LOOSENING HAD INCREASED. THE SURGEON REVISED THE AMISTEM-P COLLARED SIZE 3 TO A QUADRA-P CEMENTED SIZE 2, THE 36MM BIOLOX HEAD S TO AN HEAD L, THE HOODED PE HC LINER D 36/E TO A D 36/F, AND THE MPACT 3D METAL SHELL TWO HOLE D 54MM TO A MULTI HOLE D 60MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 25328462 ↗
• InjuryMay 8, 2026Osseointegration Problem

  REVISION SURGERY DUE TO ACETABULAR CUP LOOSENING AFTER ABOUT 2 YEARS AND 10 MONTHS FROM PRIMARY. THE PATIENT STATED THAT PAIN BEGAN AFTER STANDING FROM A SEATED POSITION. THE SURGEON REVISED THE MEDACTA ACETABULAR CUP AND LINER WITH A COMPETITOR CUP AND LINER AND REVISED THE 36MM BIOLOX HEAD L TO A 28MM BIOLOX OPTION HEAD WITH SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 25123191 ↗
• InjuryMar 27, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 3 YEARS AND 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP. THE SURGEON REVISED THE CUP, LINER AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21709025 ↗
• InjuryJul 8, 2022Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE OF THE LOOSE CUP IS UNKNOWN. AT 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14955243 ↗
• InjuryJul 6, 2021Malposition of Device; Malposition of Device

  11 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO AN ANTEVERTED CUP. THE CAUSE OF THE ANTEVERTED CUP IS UNKNOWN. THE SURGEON REVISED THE HEAD, CUP AND LINER.

  Patient problems: Insufficient Information

  MAUDE report 12119764 ↗
• InjuryJul 15, 2019Loose or Intermittent Connection

  7 DAYS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR A LOOSE SHELL. CUP, LINER AND SCREW REVISED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8789417 ↗