Mpact 3D Metal 01.38.052DHRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630030812590), received between Feb 22, 2019 and Apr 17, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Positioning Problem” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2026Osseointegration Problem; Positioning Problem

  THE PATIENT HAD PAIN AS A RESULT OF A LOOSE CUP. AT ABOUT 2 YEARS AND 8 MONTHS POST PRIMARY THE SURGEON REVISED THE MEDACTA CUP AND LINER TO A COMPETITOR CUP AND LINER, AND REVISED THE MEDACTA COCR Ø36MM HEAD TO A MEDACTA 28MM BIOLOX OPTION HEAD WITH SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS REPORTED BY THE AGENT THAT AN FIBROUS BUILDUP (CAUSED ORIGINIALLY BY A SUBOPTIMAL POSITIONING OF THE SHELL) IN THE JOINT COULD HAVE CONTRIBUTED TO THE IMPLANT LOOSENING, BUT THERE IS NO CONFIRMATION THAT THIS COULD BE THE REASON FOR REVISION AND PATIENT PAIN AND SUCCESSIVE LOOSENING.

  Patient problems: Aseptic loosening

  MAUDE report 24911611 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PAIN DUE TO A MISPOSITIONED CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER TO COMPETITOR COMPONENTS AND THE MEDACTA HEAD TO A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE CAUSE OF THE MALPOSITIONED CUP IS UNKNOWN. THE HEAD WAS REVISED TO ADD MORE STABILITY.

  Patient problems: Pain

  MAUDE report 22343744 ↗
• InjuryMar 1, 2024Positioning Problem; Positioning Problem

  REVISION SURGERY DUE TO PAIN AND CUP POSITIONED TOO VERTICAL, AT ABOUT 1 YEAR 5 MONTHS AFTER PRIMARY. CUP, LINER AND HEAD REVISED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 18817503 ↗
• InjuryJul 5, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 4 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO ILIOPSOAS TENDONITIS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER TO COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD TO A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inflammation

  MAUDE report 17256405 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING GROIN PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON BELIEVED THAT A LOOSE ACETABULAR IMPLANT WAS PRESENT. DURING THE REVISION SURGERY (AT ABOUT 2 YEARS AND 5 MONTHS FROM PRIMARY), HOWEVER, THE SURGEON NOTED THAT THE JOINT WAS STABLE AND THE CUP WAS DIFFICULT TO REMOVE. THE SURGEON DID OBSERVE THAT THERE WAS CIRCUMFERENTIAL BONY INGROWTH AS HE REMOVED THE CUP. THE SURGEON REVISED THE MEDACTA CUP, LINER, AND SCREWS WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO COMMENT FROM THE SURGEON ABOUT A POSSIBLE REASON OF PATIENT'S PAIN. THE SURGEON HAS NO REASON/THEORY ABOUT WHAT THE CAUSE OF THE PAIN WAS.

  Patient problems: Pain

  MAUDE report 16435539 ↗
• InjuryJul 26, 2021Failure to Osseointegrate

  THE PATIENT CAME IN REPORTING PAIN DUE TO THE CUP NOT GROWING IN. THE CAUSE OF THE CUP NOT GROWING IN IS UNKNOWN. 3 MONTHS AFTER PRIMARY THE SURGEON REVISED THE CUP AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12224557 ↗
• MalfunctionFeb 22, 2019Separation Problem

  DURING THE PRIMARY HIP SURGERY AND AFTER IMPACTING THE 52MM CUP, IT WAS DISCOVERED THAT THE IMPACTOR HANDLE WOULD NOT DISENGAGE FROM THE CUP. THE SURGEON REMOVED THE ORIGINAL CUP AND IMPLANTED A DIFFERENT 52MM CUP USING A DIFFERENT IMPACTOR HANDLE WITH NO ISSUES. THERE WAS A 5 MINUTE DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8361559 ↗