Mpact Acetabular System 01.32.3239HCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07630030811845), received between Mar 2, 2018 and Jun 28, 2023 — classified as 24 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  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 SUCCESSFULLY THE HEAD AND LINER.

  Patient problems: Unspecified Infection

  MAUDE report 17215241 ↗
• InjuryMay 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 5 YEARS 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 16900772 ↗
• InjuryFeb 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY FOR JOINT DISLOCATION AT ABOUT 1 MONTH POST PIRMARY. CERAMIC HEAD DISLOCATED FROM THE MPACT 3D METAL LINER.

  Patient problems: Pain

  MAUDE report 16322506 ↗
• InjuryNov 22, 2022Device 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 20 DAYS 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 15843476 ↗
• InjuryNov 15, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 20 DAYS 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 15797443 ↗
• InjuryOct 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 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 15637254 ↗
• InjuryApr 5, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  AT 1 YEAR AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. 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: Joint Dislocation

  MAUDE report 14010607 ↗
• InjuryMar 19, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT REPORTING PAIN. THE SURGEON SUSPECTED THAT A LOOSE CUP WAS THE CAUSE OF PAIN. AT 1 YEAR AND 4 MONTHS AFTER PRIMARY DURING THE REVISION SURGERY, THE SURGEON FOUND THE CUP WAS WELL FIXED AND DECIDED TO ONLY REVISE THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE CAUSE OF THE PAIN IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 13820177 ↗
• InjuryFeb 7, 2022Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 13468972 ↗
• InjuryDec 23, 2021Appropriate Device Problem Term/Code Not Available

  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 13074871 ↗
• InjuryAug 2, 2021Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 12258631 ↗
• InjuryJul 26, 2021Unstable

  REVISION SURGERY WAS PERFORMED 1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY DUE TO SUSPICION OF STEM MOBILIZATION. PRE-REVISION X-RAYS SUGGESTED STEM MOBILIZATION. DURING THE SURGERY, IT WAS CONFIRMED THAT THE STEM WAS WELL FIXED AND THE SURGEON PUT SOME BONE CHIPS DOWN THE STEM (THE REASON IS UNKNOWN) AND REPLACED THE HEAD AND LINER DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 12224595 ↗
• InjuryMar 23, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY WAS PERFORMED ABOUT 7 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY DUE TO AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND THE LINER BY POSTERIOR APPROACH.

  Patient problems: Unspecified Infection

  MAUDE report 11551149 ↗
• InjuryFeb 12, 2021Unstable

  THE PATIENT CAME IN AFTER 4 MONTHS FROM THE PRIMARY SURGERY REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER (THE SAME SIZE) AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO IMPLANT MOBILIZATION.

  Patient problems: Joint Laxity

  MAUDE report 11320657 ↗
• InjuryMar 17, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE CUP, LINER, AND HEAD 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 9845067 ↗
• InjuryMar 9, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REMOVED ALL COMPONENTS FROM THE PATIENT AND THEN PUT BRAND NEW CLEAN IMPLANTS IN THE PATIENT 12 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9804583 ↗
• InjuryFeb 6, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED AFTER 1 YEAR AND 4 MONTHS FROM THE PRIMARY DUE TO PAIN. THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE LINER AND STEM TO GET MORE ANTEVERSION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 9676073 ↗
• InjuryDec 6, 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 IMPLANTED AN ANTIBIOTIC SPACER 2 MONTHS AND 3 WEEKS AFTER PREVIOUS SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9424380 ↗
• InjurySep 17, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AFTER ABOUT 2 MONTHS FROM PRIMARY, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9075826 ↗
• InjuryMar 29, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY AFTER ABOUT ONE MONTH AFTER THE PRIMARY SURGERY DUE TO INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND REVISED THE CERAMIC HEAD AND THE CUP INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8464661 ↗
• InjuryFeb 21, 2019Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2019 WE WERE INFORMED ABOUT A PATIENT WHO CAME IN DUE TO INFECTION. ON THE FOLLOWING DAY A REVISION SURGERY WAS PERFORMED 1 YEAR AFTER PRIMARY SURGERY. THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED THE STEM, HEAD, LINER AND CUP AND IMPLANTED ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8357674 ↗
• InjuryOct 24, 2018Unstable; Device Dislodged or Dislocated

  ON (B)(6) 2018 WE WERE INFORMED THAT THE PATIENT CAME IN COMPLAINING OF INSTABILITY: THE HEAD HAD DISLOCATED FROM THE LINER 2 MONTHS AFTER THE PRIMARY. THE SURGEON REVISED THE HEAD AND LINER ON THE FOLLOWING DAY. THE SURGEON DETERMINED THE DISLOCATION WAS CAUSED BY CAPSULAR IMPINGEMENT AND NOT IMPLANT RELATED. IT WAS DETERMINED THAT MORE OFFSET THROUGH THE ACETABULAR SIDE OR FEMORAL SIDE COULD HAVE AIDED IN MAKING THE PATIENT MORE STABLE DURING INDEX PROCEDURE. BECAUSE THERE WAS NOT ENOUGH OFFSET THE SURGEON SAW WHAT HE THOUGHT WAS AN ECCENTRIC POSITION OF THE HEAD IN THE LINER. WITH THE ABSENCE OF AN OFFSET LINER AND RELUCTANCE TO PULL A WELL FIXED STEM, THE SURGEON WENT TO AN ELEVATED LINER/AND LONGER NECK ON THE 32MM HIP BALL.

  Patient problems: Joint Disorder

  MAUDE report 8000028 ↗
• InjuryMar 14, 2018Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 SURGEON NOTIFIED THE SALES REPRESENTATIVE THAT PATIENT CAME IN COMPLAINING OF REOCCURRING HIP DISLOCATION. THE CAUSE OF THE DISLOCATION IS UNKNOWN AT THIS TIME. THE REVISION DATE HAS NOT BEEN SCHEDULED YET.

  Patient problems: Joint Disorder

  MAUDE report 7338235 ↗
• InjuryMar 2, 2018Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY WITH ANOTHER COMPANY'S PRODUCT. THE PATIENT WAS INFECTED AND HAD A SPACER IMPLANTED. ON (B)(6) 2018 THE SURGEON IMPLANTED MEDACTA PRODUCTS AND TWO DAYS AFTER IMPLANTATION THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO DISLOCATION. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 7309117 ↗