Mpact Acetabular System 01.32.3644HCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 07630030812118), received between Aug 3, 2017 and Aug 27, 2026 — classified as 92 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (20 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 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Device Appears to Trigger Rejection

  The patient came in due to signs of infection and the pathogen is unknown. About 4 months after the primary surgery, the surgeon performed a washout, I&D, and revised the 36mm Biolox Head M and D 36/E Flat PE HC liner to a same size head and liner. The surgery was completed successfully.

  Patient problems: Medical device site infection

  MAUDE report 50474953 ↗
• InjuryJul 8, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY SURGERY WITH COMPETITOR IMPLANTS. ON (B)(6), 2025, THE PATIENT WAS REVISED TO A MEDACTA ACETABULAR SHELL D 52 MULTI-HOLE AND FLAT PE HC LINER D 36/E. PRESENTLY, ON (B)(6), 2026, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FLAT PE HC LINER D 36/E TO A DOUBLE MOBILITY HC LINER D 28/DMC WITH DM CONVERTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25747753 ↗
• InjuryApr 30, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER ABOUT 11 MONTHS FROM PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND THE LINER WITH A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25039775 ↗
• InjuryJan 29, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER AND HEAD TO A SAME SIZE LINER AND SAME SIZE BIOLOX OPTION HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24208598 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED AFTER 1 YEAR AND 1 MONTH FROM THE PRIMARY PROCEDURE DUE TO INSTABILITY. THE PATIENT HAD PREVIOUSLY EXPERIENCED A DISLOCATION, WHICH WAS TREATED WITH A CLOSED REDUCTION. THE SURGEON REVISED THE LINER. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: Joint Laxity

  MAUDE report 23920162 ↗
• InjuryDec 2, 2025Implant subsidence; Implant subsidence

  THE PATIENT CAME IN REPORTING INSTABILITY AND STEM SUBSIDENCE. IT HAS BEEN REPORTED THAT THE PATIENT DISLOCATED 2 TIMES, BUT IT IS NOT CONFIRMED AND NO ADDITIONAL INFO ARE AVAILABLE. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA LINER TO A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 23694044 ↗
• InjuryNov 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AFTER 8 YEARS AND 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASH OUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23462130 ↗
• InjuryNov 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AFTER 2 MONTHS FROM THE PRIMARY THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23461661 ↗
• InjuryJul 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY ON (B)(6) 2023. ON (B)(6) 2025, 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 (EMDR 3005180920-2025-00570). ON (B)(6) 2025, 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 22508124 ↗
• InjuryJul 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AFTER 1 MONTH FROM THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE HEAD AND LINER WERE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22493616 ↗
• InjuryMar 19, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 7 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 21642257 ↗
• MalfunctionJan 22, 2025Fracture; Fracture

  AFTER THE LINER WAS IMPACTED, A PROTRUSION AND A CRACK WAS FOUND ON THE SURFACE. SURGERY COMPLETED SUCCESSFULLY USING A BACK-UP. ABOUT 30-MINUTE DELAY OCCURRED TO REMOVE THE LINER AND IMPLANT A NEW ONE. TOTAL SURGERY TIME 1.5 HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21206457 ↗
• InjurySep 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 20237376 ↗
• InjuryAug 28, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 6 MONTHS AFTER PRIMARY, 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. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20083770 ↗
• InjuryJul 23, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19806171 ↗
• InjuryJun 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2023. ON (B)(6) 2024 THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED SUCCESSFULLY THE HEAD AND LINER. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT LUXATION AND THE CAUSE IS UNKNOWN. THE CUP WAS MALPOSITIONED IN THE PRIMARY SURGERY AND PROBABLY THIS CAUSED THE DISLOCATION. THE SURGEON REVISED THE HEAD, CUP AND LINER AND IMPLANTED A DOUBLE MOBILITY CUP AND LINER AND BALL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT BONE QUALITY WAS EXCELLENT.

  Patient problems: Joint Dislocation

  MAUDE report 19566894 ↗
• InjuryApr 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION AT ABOUT 3 MONTHS FROM PRIMARY DUE TO A JOINT LUXATION. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 19088379 ↗
• InjuryFeb 7, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2023. ON (B)(6) 2023, 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, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18659378 ↗
• InjuryDec 5, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 6 MONTHS AFTER THE PRIMARY, 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. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18266874 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 6 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17973641 ↗
• InjuryOct 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 3 MONTHS AND A HALF FROM 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 17911021 ↗
• InjurySep 20, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  DURING THE HIP SURGERY, THE TRIAL REDUCTION WAS PERFORMED USING A CUP 52MM, LINER 36MM, AND HEAD 36MM, SLEEVE S. SINCE THERE WAS NO DISLOCATION TENDENCY, THE IMPLANTS OF THE SAME SIZES WERE INSERTED IN THE SAME POSITIONS AS TRIALS. HOWEVER, IT WAS NOTICED THAT THE IMPLANT TENDED TO DISLOCATE. IN ADDITION, CUP FIXATION WAS POOR. THE SURGERY WAS SUCCESSFULLY COMPLETED USING A CUP 54 MM, LINER 36 MM AND HEAD, SLEEVE M.

  Patient problems: Pain

  MAUDE report 17779522 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 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 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17728522 ↗
• InjuryJul 28, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 6 YEARS AND 7 MONTHS FROM 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 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17413518 ↗
• InjuryJul 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

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

  Patient problems: Unspecified Infection

  MAUDE report 17361570 ↗