Mpact Acetabular System 01.32.3641HC4Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630040731010), received between Nov 3, 2020 and Dec 22, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2021Device Dislodged or Dislocated

  AT 5 MONTHS AFTER THE LAST SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER TO A COMPETITOR COMPONENT AND REVISED THE MEDACTA HEAD TO A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON REVISED THE CUP TO CHANGE ITS POSITION. THE CUP WAS MALPOSITIONED, SO AFTER REPOSITIONING THE PATIENT WOULD NOT DISLOCATE AS EASILY NOW. THIS IS THE SECOND REVISION SURGERY PERFORMED DUE TO HEAD-LINED DISLOCATION FOR THIS PATIENT.

  Patient problems: Joint Dislocation

  MAUDE report 13058895 ↗
• InjuryNov 3, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER 8 MONTHS AFTER THE PRIMARY SURGERY. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON CONVERTED THE MPACT CUP TO A DUAL MOBILITY CUP, AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE BALL HEAD IS A COMPETITOR PRODUCT. THE SURGEON USED POSTERIOR-LATERAL APPROACH DURING THE PRIMARY SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 10778505 ↗