Mpact Acetabular System 01.32.156DHRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07630030810855), received between Jul 7, 2017 and Mar 16, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Fracture” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Fracture

  THE PATIENT HAD PAIN DUE TO THE ACETABULAR CUP PUSHING INTO THE ACETABULUM CAUSING ACETABULAR PERFORATION. THE SURGEON 2 WEEKS AFTER PRIMARY OBSERVED POOR BONE QUALITY WHICH LED TO THE CUP PUSHING INTO THE BONE. THE SURGEON REVISED THE MEDACTA BIOLOX HEAD TO A MEDACTA COCR HEAD SIZE S AND REVISED THE MEDACTA LINER AND CUP TO A COMPETITOR LINER AND CUP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 24603543 ↗
• InjuryOct 31, 2025Fracture; Failure to Osseointegrate; Fracture; Failure to Osseointegrate

  ABOUT 3 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME REPORTING PAIN DUE TO A LOOSE CUP. THE SURGEON REVISED THE CUP, SCREWS (ONE WAS FOUND BROKEN), HEAD, AND LINER TO A COMPETITOR'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 23434514 ↗
• InjuryFeb 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  (B)(6)2024 THE PROSTHESIS WAS IMPLANTED IN ROSENKLINK. (B)(6)2024 IMPLANT-ASSOCIATED EARLY INFECTION WITH S. EPIDERMIS. (EXTERNAL). (B)(6)2024 ONE-STAGE CHANGE OF RIGHT HIP TP FROM ANTERIOR, SAMPLES COLLECTED. (EXTERNAL). (B)(6)2024 EXPLANTATION OF TOTAL HIP PROSTHESIS RIGHT WITH IMPLANTATION OF SPACER. (EXTERNAL).

  Patient problems: Medical device site infection

  MAUDE report 21320607 ↗
• InjuryOct 3, 2024Osseointegration Problem; Osseointegration Problem

  DURING A CT SCAN CONTROL THE SURGEON NOTICED SOME POINTS ON THE SHELL WHERE THE BONE IS NOT GROWING. REVISION PERFORMED ON (B)(6) 2024. CUP, LINER AND HEAD WERE REVISED. PRIMARY SURGERY DATA NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359047 ↗
• InjuryMar 6, 2024Osseointegration Problem; Osseointegration Problem

  AT 11 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE CUP HAD NOT GROWN IN PROPERLY. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18845575 ↗
• InjuryFeb 23, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  AT 1 MONTH AND A HALF AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 13584649 ↗
• InjuryFeb 7, 2022Appropriate Device Problem Term/Code Not Available

  AT ABOUT 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13469160 ↗
• InjuryFeb 7, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

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

  Patient problems: Pain

  MAUDE report 13469120 ↗
• InjuryFeb 1, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  AT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN FOLLOWING DISLOCATION OF THE JOINT DUE TO AN OVERLY ANTEVERTED CUP. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 13415521 ↗
• InjuryOct 27, 2021Malposition of Device; Malposition of Device

  AT 1 YEAR AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN. THE SURGEON DETERMINED THERE WAS ANTERIOR INSTABILITY DUE TO CUP MALPOSITIONING AND HETEROTOPIC OSSIFICATION(SEPARATE PROBLEMS). THE SURGEON REMOVED THE BONE AND CHANGED OUT THE LINER FOR A FACE-CHANGING LINER AND A LARGER HEAD SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 12703052 ↗
• InjuryJul 8, 2021Appropriate Device Problem Term/Code Not Available

  3 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12133588 ↗
• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED DUE TO CUP MOBILIZATION 8 MONTHS AFTER THE PRIMARY SURGERY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11804380 ↗
• InjuryOct 20, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, 3 YEARS AND 11 MONTHS AFTER PRIMARY SURGERY, REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE CUP AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10703211 ↗
• InjuryJun 23, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 7 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF INFECTION AND THE PATHOGEN HAS BEEN IDENTIFIED AS (B)(6). THE SURGEON PERFORMED WASHOUT, REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10183416 ↗
• InjuryJan 13, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REMOVED THE CUP, HEAD AND LINER 7 WEEKS AFTER PRIMARY. A NEW HEAD AND LINER WERE CEMENTED IN PLACE TO ACT AS A TEMPORARY SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9580028 ↗
• InjurySep 3, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 1 MONTH AND A HALF AFTER PRIMARY SURGERY THE SURGEON REVISED THE PATIENT HIP FOR INFECTION. THE PATHOGEN IS UNKNOWN, ALL IMPLANTS REVISED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8955359 ↗
• InjurySep 2, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ON (B)(6) 2019 WE WERE INFORMED THAT THE SURGEON WOULD HAVE REMOVED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER ON (B)(6) 2019 (1 YEAR AND 5 MONTHS AFTER PRIMARY). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8953726 ↗
• InjuryJun 21, 2019Detachment of Device or Device Component

  DURING THE PRIMARY HIP SURGERY, AND WHILE USING A BLUE OFFSET INSERTER, THE CUP POPPED OFF THE DEVICE. AS THE SURGEON TRIED TO THREAD THE INSERTER INTO THE CUP, THE THREADS BECAME CROSS THREADED. ANOTHER CUP WAS USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS A 15 MINUTE DELAY IN THE CASE. IT IS NOT KNOWN IF THE INSTRUMENT THREAD WAS DAMAGED. THE SAME INSTRUMENT WAS USED FOR THE SECOND CUP PLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8721538 ↗
• InjuryMay 14, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 2 MONTHS AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE CUP, THE LINER, THE HEAD AND THE STEM WITH ANOTHER COMPANY'S PRODUCTS FOR A HIP INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8607925 ↗
• InjuryNov 27, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER ABOUT 1 YEAR AND 3 MONTHS DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN AT THIS TIME. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED A SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 8105806 ↗
• InjuryMay 23, 2018Loose or Intermittent Connection

  ON (B)(6) 2018 WE WERE INFORMED THAT PATIENT PRESENTED TO SURGEON WITH PAINFUL HIP FROM PREVIOUS SURGERY. XRAYS REVEALED LUCENT LINE AROUND CUP. SUBSECTION OF CUP LOOSENING. REVISION SURGERY BOOKED FOR (B)(6). ON (B)(6) 2018 THE REVISION SURGERY WAS PERFORMED. THE SURGEON REVISED THE PATIENT FOR CUP LOOSENING. CUP, LINER AND HEAD SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7536830 ↗
• InjuryJul 7, 2017Insufficient Device Problem Information

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON PERFORMED AN I AND D AND REVISED ALL MEDACTA HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 6692848 ↗