Mpact Acetabular System 01.32.4048HCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07630030812262), received between Sep 29, 2017 and Aug 27, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Device Dislodged or Dislocated

  Revision surgery due to joint luxation after about 2 months from primary. The surgeon revised the proximal body, Biolox head and liner along with a DM converter. The surgery was completed successfully.

  Patient problems: Joint Dislocation

  MAUDE report 50474971 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  The initial canal finder and subsequent broaches exited through the posterior femoral cortex. No bone fracture was reported. The femur was subsequently re-broached and prophylactic cables were applied to reduce the risk of postoperative fracture. At the end of the primary procedure, the hip was considered stable by the surgeon. However, a postoperative dislocation of the femoral head from the cup/liner construct occurred in the recovery area on the same day. The patient subsequently underwent revision surgery due to pain associated with the dislocation. During revision, the D 40/F Flat PE HC liner was replaced with a D 40/F 10° face-changing PE HC liner. The revision procedure was completed successfully.

  Patient problems: Joint Dislocation

  MAUDE report 50474961 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 MONTHS FROM PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY. THE SURGEON REVISED THE LINER TO A FACE CHANGING FOR STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24208605 ↗
• InjuryAug 13, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19971501 ↗
• InjuryApr 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19178925 ↗
• InjuryNov 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SURGERY ON (B)(6) 2022. ON (B)(6) 2022, PATIENT CAME IN FOR A POST-OP APPOINTMENT AND THE SURGEON OBSERVED THAT THE CUP DID NOT SIT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 15778464 ↗
• InjuryOct 5, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Medical device site infection

  MAUDE report 15542498 ↗
• InjuryJun 28, 2022Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 14839490 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER 1 MONTH AFTER THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12851445 ↗
• InjuryNov 2, 2021Appropriate Device Problem Term/Code Not Available

  AT 1 YEAR 3 MONTHS AFTER THE PRIMARY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12736481 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER 12 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10984789 ↗
• InjuryJun 10, 2020Device Dislodged or Dislocated

  THE PATIENT CAME IN, 4 YEARS AND 6 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO A DISLOCATION OF A COMPETITOR'S HEAD FROM THE MEDACTA LINER. THE SURGEON REVISED THE FLAT LINER TO A 10 DEGREE FACE CHANGING LINER AND REVISED THE COMPETITOR'S HEAD WITH ANOTHER COMPANY'S HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 10136926 ↗
• InjuryMar 13, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY AFTER 28 DAYS FROM THE PRIMARY SURGERY DUE TO SIGNS OF INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8417221 ↗
• InjuryMar 27, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AFTER ABOUT 14 MONTHS FROM THE PRIMARY. THE PATHOGEN IS NOT AVAILABLE. THE SURGEON WASHED OUT THE HIP AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7372844 ↗
• InjuryOct 12, 2017Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON WASHED OUT THE HIP AND SWAPPED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 6944507 ↗
• InjurySep 29, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON PERFORMED AN I & D AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 6903974 ↗