Mpact Acetabular System 01.32.3248HCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630030811951), received between Feb 21, 2018 and Jun 24, 2021 — classified as 7 injuries, 1 malfunction.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 1 MONTH AFTER PRIMARY FOR LUXATION OF THE HEAD FROM LINER (HAPPENED DURING REHAB). DOUBLE MOBILITY CONVERTER IMPLANTED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 12056933 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER, 3 YEARS 4 MONTHS AFTER THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11130978 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PAIN AND COULD NOT STAND ON THE LEG - THROUGH RADIOLOGICAL EXAMINATION, THE SURGEON SAW SOME OSTEOLYSIS ON THE CUP. HE DECIDED TO REMOVE IT AND TO IMPLANT A NEW ONE, 3 MONTHS AFTER PRIMARY SURGERY. SINCE THE BONE WAS NOT GOOD ENOUGH, WE HAD TO IMPLANT A CEMENTED ONE.

  Patient problems: Osteolysis

  MAUDE report 11027612 ↗
• InjuryNov 17, 2020Material Deformation

  1 MONTH AFTER PREVIOUS REVISION SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PREVIOUSLY THE PATIENT HAD REVISED AL COMPONENTS DUE TO SUBSIDENCE OF THE TIBIAL COMPONENT ON (B)(6) 2020. ON (B)(6) 2018 THE PATIENT HAD AN INFECTION AND LINER REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 10852298 ↗
• InjuryNov 16, 2020Device Dislodged or Dislocated

  WHILE THE PATIENT WAS IN POST-OP RECOVERY, THE PATIENT HEAD DISLOCATED FROM THE LINER. THE CAUSE FOR THE DISLOCATION WAS AN ANTEVERTED CUP. THE SURGEON REVISED THE PATIENT'S CUP, HEAD, AND LINER THE SAME DAY OF PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 10843088 ↗
• InjuryJun 25, 2018Unstable

  THE PATIENT CAME IN COMPLAINING OF PAIN AND INSTABILITY. THE CAUSE OF PAIN AND INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFO RECEIVED BY MEDACTA USA ON THE "4TH JULY 2018": IT IS UNKNOWN IF THE INSTABILITY CAUSED THE PAIN. NO SURGEON COMMENT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7634078 ↗
• MalfunctionApr 11, 2018Residue After Decontamination; Device Operates Differently Than Expected

  THE DEFINITIVE LINER WAS OPENED FOR IMPLANTATION DURING SURGERY, IT WAS NOTICE BEFORE IMPLANTATION THERE WAS AN ISSUE. THE INLAY HAS A RESIDUAL OF PE ON THE POLAR REGION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7421488 ↗
• InjuryFeb 21, 2018Device Dislodged or Dislocated

  ON (B)(6) 2018 MEDACTA SALES REPRESENTATIVE WAS INFORMED BY THE SURGEON THAT A REVISION SURGERY WILL BE NECESSARY. REVISION SURGERY PERFORMED ON (B)(6) 2018 DUE TO MULTIPLE LUXATION. INSERT AND HEAD WERE REVISED .

  Patient problems: Joint Dislocation

  MAUDE report 7285369 ↗