Mpact Acetabular System 01.32.3241HCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 07630030811876), received between Nov 8, 2017 and Mar 10, 2026 — classified as 34 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (18 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION 5 YEARS AND 5 MONTHS AFTER PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE D 32/D LINER TO A SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24558197 ↗
• InjuryDec 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME HAD HIP PAIN AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 11 MONTHS POST PRIMARY THE SURGEON REVISED THE MEDACTA CUP AND LINER TO A COMPETITOR CUP AND LINER AND REVISED THE MEDACTA HEAD TO A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 23858473 ↗
• MalfunctionNov 5, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE LINER COULD NOT BE INSERTED INTO THE CUP. THERE WAS NO LIFTING OF THE SCREWS OR THE CENTRAL PLUG. A NEW LINER (FROM A DIFFERENT LOT) WAS USED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. 30 MIN DELAY TO REMOVE THE LINER AND IMPLANT A NEW ONE (TOT TIME 2 HOURS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477195 ↗
• InjuryFeb 11, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 7 YEARS AND 4 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 HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21353078 ↗
• MalfunctionOct 18, 2024Positioning Problem; Positioning Problem

  THE LINER COULD NOT BE PLACED INTO THE CUP. DURING LINER IMPACTION ATTEMPTS, THE CUP CHANGED POSITION, SO IT HAD TO BE REPOSITIONED AND THE SCREW ALREADY PLACED WAS REMOVED. CUP WAS WELL FIXED AND WAS IMPLANTED WITH NO SCREW, AS THE ORIENTATION OF THE SCREW HOLES MADE DRILLING DIFFICULT. A NEW LINER WAS USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ABOUT 20 MINUTES DELAY OCCURRED DUE TO THE ISSUE; TOTAL SURGERY TIME 2 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20479341 ↗
• InjuryFeb 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. AT 7 YEARS AND 4 MONTHS POST PRIMARY THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18657234 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 MONTH 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 AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17727778 ↗
• InjuryJun 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE LINER AND THE HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 17190145 ↗
• InjuryMay 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A JOINT LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD AND REVISED THE MEDACTA CUP AND LINER WITH A COMPETITOR CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 16900939 ↗
• InjuryMar 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 9 MONTHS AND 1 WEEK THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE CUP, HEAD AND LINER.

  Patient problems: Implant Pain

  MAUDE report 16655188 ↗
• InjuryMar 7, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO JOINT LUXATION. THE SURGEON REVISED THE COMPETITOR HEAD AND MEDACTA LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 16494448 ↗
• InjuryApr 27, 2022Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 14218338 ↗
• InjuryMar 3, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  AT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO POSTERIOR LUXATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER WITH DOUBLE MOBILITY AND INSERTED A CONVERTER DM. THE HEAD AND STEM WERE NOT MEDACTA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 13658053 ↗
• InjuryFeb 28, 2022Device Dislodged or Dislocated

  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 HEAD AND LINER 6 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. AN ANTERIOR APPROACH WAS USED DURING PRIMARY. THIS EVENT TOOK PLACE IN 2019 BUT THE REVISION TICKET WAS LABELED AS "NON-MEDACTA REVISED". ONLY NOW IT HAS BEEN DISCOVERED THAT MEDACTA DEVICES WERE REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 13617787 ↗
• InjuryJan 26, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 2 MONTHS FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 13357842 ↗
• InjuryDec 10, 2021Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 12974207 ↗
• InjuryNov 24, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD 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. PRESENTLY, ON (B)(6) 2021, 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 12867575 ↗
• InjurySep 14, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 3 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD, LINER, AND CUP. SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 12466364 ↗
• InjuryDec 13, 2020Device Dislodged or Dislocated

  REVISION SURGERY 1 MONTH AFTER PRIMARY SURGERY FOR DISLOCATION OF THE HEAD FROM LINER. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. AN ANTERIOR APPROACH WAS USED IN THE PRIMARY SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 10998938 ↗
• InjuryNov 30, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 4 YEARS AND 4 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10920070 ↗
• InjuryJul 28, 2020Device Dislodged or Dislocated

  1 DAY AFTER PRIMARY SURGERY THE SURGEON REVISED THE PATIENT STEM, HEAD, AND LINER FOR A DISLOCATION (HEAD FROM LINER). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 10331336 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN 2 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA 32MM BIOLOX DELTA HEAD S WITH A MEDACTA 32MM BIOLOX OPTION HEAD AND REVISED THE MEDACTA MPACT FLAT LINER HC 32/D WITH A MEDACTA MPACT FLAT LINER HC 32/D. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9937100 ↗
• InjuryOct 18, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 22 DAYS AFTER THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9206478 ↗
• InjuryAug 9, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER ALMOST 4 MONTHS AFTER PRIMARY. THE SURGEON REVISED THE 32MM BIOLOX HEAD S WITH A 32MM BIOLOX HEAD L. THE SURGERY WAS COMPLETED SUCCESSFULLY. WE WERE INFORMED ABOUT THE EVENT ON (B)(4), THE REVISION SURGERY WAS PERFORMED ON (B)(6).

  Patient problems: Joint Dislocation

  MAUDE report 8878377 ↗
• InjuryApr 3, 2019Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED 1 YEAR AFTER PRIMARY DUE TO RECURRENT HIP DISLOCATION (HEAD FROM LINER). AT THE FIRST DISLOCATION, THE SURGEON WAS ABLE TO REDUCE HER HIP WITHOUT SURGERY. AFTER THE SECOND RE-OCCURRENCE, THE SURGEON REVISED CUP, LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PRIMARY WAS PERFORMED IN AMIS.

  Patient problems: Joint Dislocation

  MAUDE report 8478387 ↗