Mpact Acetabular System 01.32.154DHRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07630030810824), received between Oct 26, 2017 and Sep 6, 2024 — classified as 23 injuries.

The most frequently reported specific device problem is “Malposition of Device” (4 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED DUE TO ANTERIOR HIP PAIN AT 1 YEAR AND 6 MONTHS FROM THE PRIMARY. THE CUP, LINER AND HEAD WERE REMOVED AND REPLACED WITH A DUAL MOBILITY COMPETITOR CUP.

  Patient problems: Pain

  MAUDE report 20154723 ↗
• InjurySep 5, 2024Migration; Migration

  AT ABOUT 5 YEARS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A CUP IMPINGEMENT WITH THE STEM. THE SURGEON REVISED THE HEAD WITH MEDACTA HEAD AN SLEEVE, AND LINER AND CUP WITH COMPETITOR'S DEVICES (THE CUP WAS AT 13 DEGREES SO HE CHANGED IT TO 20). SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Impingement

  MAUDE report 20147355 ↗
• InjuryJun 19, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 9 MONTHS POST PRIMARY DURING A CT SCAN CONTROL THE SURGEON NOTICED SOME POINTS ON THE SHELL WHERE THE BONE IS NOT GROWING. NO REVISION PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566390 ↗
• InjuryMay 16, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 4 MONTHS AFTER PRIMARY, 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: Medical device site infection

  MAUDE report 19328373 ↗
• InjuryDec 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2021. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. ON (B)(6) 2022, THE SURGEON REVISED THE STEM AND HEAD SUCCESSFULLY. PRESENTLY, THE PATIENT CAME IN SUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE CUP, LINER, HEAD AND PROXIMAL BODY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18364400 ↗
• InjuryDec 7, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 4 YEARS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON EXPLANTED ALL IMPLANTS AND PLACED AN ANTIBIOTIC SPACER FOR A 2-STAGE INFECTION PROTOCOL. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, PERMANENT IMPLANTS WERE PLACED (ABOUT 4 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY).

  Patient problems: Unspecified Infection

  MAUDE report 18281395 ↗
• InjuryApr 12, 2023Malposition of Device; Malposition of Device

  AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND THE SURGEON OBSERVED THAT THE PATIENT HAD A MALPOSITIONED CUP AND THE CAUSE OF THE MALPOSITIONED CUP IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16723121 ↗
• InjuryMar 10, 2023Migration; Migration

  AT ABOUT 13 DAYS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE CUP HAD SPUN OUT. THE SURGEON REVISED SUCCESSFULLY THE CUP, HEAD AND LINER. IT IS REPORTED THE PATIENT HAS POOR BONE QUALITY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16521697 ↗
• InjuryNov 24, 2022Malposition of Device; Malposition of Device

  AT ABOUT 1 YEAR 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE SURGEON DETERMINED THAT THE CUP WAS OVERLY ANTEVERTED. THE SURGEON REVISED THE MEDACTA CUP WITH A COMPETITOR CUP AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15860113 ↗
• InjuryJun 13, 2022Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING PAIN DUE TO ASEPTIC LOOSENING AND THE CAUSE IS UNKNOWN. AT ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 14673491 ↗
• InjuryOct 12, 2021Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Failure of Implant; Pain

  MAUDE report 12615764 ↗
• InjuryJul 16, 2021Unintended Movement; Appropriate Device Problem Term/Code Not Available

  3 DAYS AFTER THE PRIMARY SURGERY THE SURGEON NOTICED ON THE X-RAYS THAT THE CUP MOBILIZED. THE SURGEON REVISED THE CUP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12179426 ↗
• InjuryOct 28, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 2 MONTHS AFTER THE PRIMARY SURGERY REPORTING PAIN DUE TO A LOOSE CUP. THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 10749169 ↗
• InjurySep 8, 2020Improper or Incorrect Procedure or Method; Positioning Problem

  2 MONTHS AFTER PRIMARY THE SURGEON REVISED SUCCESSFULLY THE PATIENT HIP REMOVING THE CUP, THE LINER AND THE BALL HEAD. THE CUP MOBILIZED TO A TOO MUCH ANTEVERTED POSITION AND THE SURGEON DECIDED TO PERFORM THE REVISION SURGERY.

  Patient problems: No Code Available

  MAUDE report 10502560 ↗
• InjuryJul 14, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN 2 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF 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 10271040 ↗
• InjuryMar 4, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN, THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD, AND LINER 4 YEARS AND 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 9785161 ↗
• InjuryDec 4, 2019Malposition of Device; Malposition of Device

  REVISION SURGERY PERFORMED 9 MONTHS AFTER THE PRIMARY DUE TO LOOSE AND TILTED FEMORAL STEM AND MALPOSITIONED CUP. THE CUP AND THE STEM WERE REVISED.

  Patient problems: No Code Available

  MAUDE report 9409888 ↗
• InjuryAug 23, 2019Unstable; Malposition of Device

  THE PATIENT CAME IN, 5 MONTHS AFTER PRIMARY SURGERY, COMPLAINING OF INSTABILITY WHICH WAS DUE TO A MALPOSITIONED CUP. THE SURGEON REVISED THE CUP, LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8925185 ↗
• InjuryMay 15, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO INFECTION 5 MONTHS AFTER PRIMARY. PATIENT HAD A REOCCURRING INFECTION, HE HAD 3 WASHOUTS PRIOR WITH NO EFFECT. ASPIRATION 4 MONTHS AFTER PRIMARY SHOWED INFECTION. THE PATHOGEN IS STAPH EPIDERMIDIS.

  Patient problems: Unspecified Infection

  MAUDE report 8612051 ↗
• InjuryJan 4, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN (6 MONTHS AFTER PRIMARY SURGERY) DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON EXPLANTED THE CUP, HEAD, LINER AND STEM AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS PERFORMED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8217187 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem

  ABOUT 8 MONTH AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A HIP INFECTION. ALL HARDWARE REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8069025 ↗
• InjuryOct 30, 2018Adverse Event Without Identified Device or Use Problem

  ABOUT 12 DAYS AFTER PRIMARY THE SURGEON REVISED THE PATIENT CUP, LINER AND HEAD FOR AN INFECTION CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8019256 ↗
• InjuryOct 26, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 6979324 ↗