Mpact Acetabular System 01.32.4052HCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07630030812286), received between Nov 22, 2017 and Apr 4, 2025 — 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. 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AFTER 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: Medical device site infection

  MAUDE report 21771243 ↗
• InjuryFeb 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE COMPETITOR HEAD AND MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 21355121 ↗
• InjuryJul 26, 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 REPORTING PAIN DUE TO A FEMORAL FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024 THE PATIENT HAD SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED THE MEDACTA CUP AND LINER AND COMPETITOR STEM AND HEAD TO IMPLANT AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19836133 ↗
• InjuryApr 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2021. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD, SLEEVE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 16815521 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 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: Medical device site infection

  MAUDE report 16565476 ↗
• InjuryApr 11, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 3 YEARS 11 MONTHS AFTER THE PRIMARY DUE TO HIP LUXATION (LINER FROM HEAD). THE SURGEON REVISED THE MEDACTA LINER WITH A COMPETITOR CONSTRAINED LINER AND REVISED THE MEDACTA HEAD TO A MEDACTA HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 14072432 ↗
• InjuryJul 12, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 11 MONTHS AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12148668 ↗
• InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. 1 MONTH AFTER PRIMARY ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12134401 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem

  2 WEEKS 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 12038934 ↗
• InjuryJun 15, 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 LINER 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11999150 ↗
• InjuryAug 23, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL HARDWARE AND PUT IN AN ANTIBIOTIC SPACER 1 YEAR AND 8 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8924581 ↗
• InjuryApr 3, 2019Appropriate Device Problem Term/Code Not Available

  ON (B)(4) 2019 WE HAVE BEEN INFORMED ABOUT A PATIENT WHO HAD A PRIMARY HIP SURGERY ON (B)(6) 2015. SUBSEQUENTLY, THE PATIENT CAME IN COMPLAINING OF INSTABILITY AND THE HEAD AND LINER WERE REVISED ON (B)(6) 2016 [(B)(4)]. PRESENTLY, 2 YEARS AND 9 MONTHS FROM THE LAST REVISION, THE PATIENT CAME IN COMPLAINING OF TIGHTNESS AND SORENESS DUE TO THE INCREASED LENGTH AND ASSOCIATED OFFSET WITH THE LONGER HEAD FROM THE PREVIOUS REVISION. THE SURGEON PLANS ON REMOVING THE CURRENT HEAD AND LINER AND TRIALING A DM CONVERTER LINER AND SHORTER HEAD. THE REVISION SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2019 DUE TO THE PATIENT'S REQUEST SO THAT THE REHAB TIME DOES NOT INTERFERE WITH THE PATIENT'S WORK SCHEDULE. MORE DETAILS TO FOLLOW AFTER THE SURGERY HAS BEEN COMPLETED.

  Patient problems: Pain

  MAUDE report 8478397 ↗
• InjurySep 19, 2018Device Dislodged or Dislocated

  WE WERE INFORMED ON (B)(6) 2018 THAT A REVISION SURGERY TO BE PLANNED DUE TO HEAD DISLOCATION FROM LINER AND CUP HAPPENED 1 MONTH AFTER PRIMARY. UPDATE 22 AUGUST 2018: THE DATE IN WHICH THE REVISION WILL TAKE PLACE IS UNKNOWN. THE PATIENT WAS IN CARDIAC DISTRESS AND WAS UNABLE TO UNDERGO SURGERY.

  Patient problems: No Code Available

  MAUDE report 7888904 ↗
• InjuryAug 29, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION 10 MONTHS AFTER PRIMARY. THE PATHOGEN IS UNKNOWN. THE SURGEON WASHED OUT THE HIP AND SWAPPED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Injury

  MAUDE report 7826836 ↗
• InjuryApr 10, 2018Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 7412264 ↗
• InjuryNov 22, 2017Device Dislodged or Dislocated

  THE PATIENT CAME IN COMPLAINING OF RECURRENT DISLOCATION. THE SURGEON SWAPPED THE LINER SINCE IT DISLOCATED FROM THE HEAD (NON-MEDACTA PRODUCT). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 7052114 ↗