Mpact Acetabular System 01.32.146DHRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630030810701), received between Jul 6, 2018 and Feb 6, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2025Malposition of Device; Malposition of Device

  AT ABOUT 1 YEAR AND 7 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A MALPOSITIONED CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 21320606 ↗
• InjuryNov 16, 2023Osseointegration Problem; Appropriate Device Problem Term/Code Not Available; Osseointegration Problem; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO CUP LOOSENING, AT ABOUT 7 YEARS 7 MONTHS FROM THE PRIMARY. THE SURGEON REVISED SUCCESSFULLY CUP, LINER AND HEAD. THE PATIENT EXPERIENCED PAIN AND SUBLUXING FEELING OF THE RIGHT HIP SINCE THE PRIMARY SURGERY IN 2016. EPISODES OF JOINT LUXATION NOT CONFIRMED. THE SURGEON REPORTED SIGNS OF THE STEM IMPINGEMENT ON THE CUP IN END OF RANGE HIP FLEXION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18146682 ↗
• InjurySep 6, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A COMPLAINT WAS FILLED. ON (B)(6) 2022, 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: Unspecified Infection

  MAUDE report 15361263 ↗
• MalfunctionMay 21, 2021Migration or Expulsion of Device

  THE SURGEON NOTICED THAT THE CUP MIGRATED FROM THE PATIENT ACETABULAR AFTER THE FINAL REPOSITIONING DURING THE SURGERY. THE SURGEON REPLACED IT WITH A NEW MPACT MULTIHOLE CUP AND LINER. THE WAS 1 HOUR SURGERY TIME DELAY. TOTAL SURGERY TIME: 4 HOURS. THE SAME SIZE WAS USED FINALLY. IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS NECESSARY.

  Patient problems: Insufficient Information

  MAUDE report 11862214 ↗
• InjuryDec 10, 2019Appropriate Device Problem Term/Code Not Available

  THE IMPACT CUP WAS REMOVED BECAUSE OF THE PATIENT-REPORTED PAIN 2.5 YEARS AFTER PRIMARY SURGERY. DURING THE REVISION SURGERY, IT WAS CONFIRMED THAT THE CUP WAS PERFECTLY INTEGRATED, AND THE INFECTION SAMPLES WERE NEGATIVE.

  Patient problems: Pain

  MAUDE report 9443412 ↗
• InjuryAug 30, 2018Migration or Expulsion of Device

  THE PATIENT CAME IN COMPLAINING OF PAIN 1 YEAR AND 9 MONTHS AFTER PRIMARY SURGERY. THE SURGEON DETERMINED THAT THE CUP HAD MIGRATED OVER TIME. THE CAUSE OF THE MIGRATION IS UNKNOWN. THE SURGEON REVISED THE CUP, LINER AND HEAD. THE SURGEON REVISED THE CUP AND LINER WITH ANOTHER COMPANY'S PRODUCT. THE SURGEON REVISED THE HEAD WITH ANOTHER MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant; No Code Available; Pain

  MAUDE report 7832924 ↗
• InjuryJul 6, 2018Device Dislodged or Dislocated

  WE WERE INFORMED ON 08 JUNE 2018 THAT BEFORE PRIMARY SURGERY THE HIP WAS FOUND DISLOCATED: THE SURGEON WAS ABLE TO PUT THE HIP IN PLACE IN PRE-OP WITH LITTLE EFFORT. THEN, DURING THE PRIMARY SURGERY, AN MPACT 2 HOLE SHELL WAS USED, BUT NO SCREWS WERE USED SINCE THE DOCTOR DETERMINED IT FELT SOLID. THE NEXT DAY THE PATIENT CONTINUED WITH PAIN: THE SHELL WAS FOUND MISPLACED. ON (B)(6) 2018 WE WERE INFORMED THAT THE SURGEON REVISED THE CUP, HEAD, LINER AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY

  Patient problems: Failure of Implant; Joint Dislocation; Pain

  MAUDE report 7666247 ↗