Mpact Acetabular System 01.32.3648HCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 07630030812132), received between Sep 7, 2017 and Jan 23, 2026 — classified as 60 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (14 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 61 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR FROM THE PRIMARY, THEPATIENT CAME IN DUE TO INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE 36MM BIOLOX HEAD TO A 28MM BIOLOX HEAD, AND REVISED THE FLAT PE HC LINER D 36/F LINER TO A DOUBLE MOBILITY D 28 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24162757 ↗
• InjuryOct 15, 2025Naturally Worn; Naturally Worn

  THE PATIENT HAD PRIMARY HIP SURGERY ON (B)(6) 2019 TREATMENT OF OSTEOARTHRITIS. DURING A FOLLOW-UP (AT ABOUT 6 YEARS AND 5 MONTHS POST PRIMARY), THE SURGEON NOTICED THAT THE HEAD LOOKED ECCENTRIC INSIDE THE POLY, WHICH COULD POSSIBLY INDICATE POLYETHYLENE WEAR. THE PATIENT REPORTS NO PAIN. HIS ACTIVITY LEVEL IS PRETTY HIGH. HE REGULARLY WORKS OUT AND PLAYS TENNIS. THERE IS NO PLAN FOR A REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289849 ↗
• InjuryNov 25, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 5 YEARS AND 10 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 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20770828 ↗
• InjuryJul 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 MONTHS AFTER THE PRIMARY, 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. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 19790253 ↗
• InjuryFeb 28, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 4 YEARS AND 10 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AFTER TRIPPING AND FEELING A POP SEVERAL MONTHS BEFORE THE REVISION DATE. DURING THE REVISION AT THE DISTAL PART OF THE STEM THE BONE WAS VERY HARD AND THIS WAS PROBABLY DUE TO A FEMORAL BONE FRACTURE THAT HAS HEALED, BUT NOT NOTICED BEFORE. THE STEM WAS EXPLANTED USING MEDACTA STEM REMOVAL SYSTEM AND WAS EASY TO REMOVE IT. IMPLANTING THE NEW STEM, FLEXIBLE REAMERS WERE NEEDED TO PERFORM DISTAL FEMUR REAMING BECAUSE OF THE HARD BONE LIKELY DUE TO THE HEALED BONE FRACTURE. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR PRODUCTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18795922 ↗
• InjuryJan 9, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY FOR SUSPECTED INFECTION AT ABOUT 1 MONTH FROM PRIMARY. THE HEAD AND LINER HAVE BEEN REVISED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18474104 ↗
• InjuryJul 13, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP 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 HEAD AND LINER (EMDR 2022-00792). THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, 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 17316329 ↗
• InjuryMar 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS 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 HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16590957 ↗
• InjuryMar 7, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 1 YEAR 5 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LEG LENGTH DISCREPANCY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD AND LINER (36 TO 40 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 16494447 ↗
• InjuryFeb 8, 2023Device 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 1 MONTH FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16322503 ↗
• InjuryNov 28, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, REVISION WAS PERFORMED DUE TO INFECTION. THE SURGEON REVISED SUCCESSFULLY THE HEAD AND THE LINER.

  Patient problems: Unspecified Infection

  MAUDE report 15869292 ↗
• InjuryNov 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 15 DAYS 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 THE HEAD, STEM, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 15788512 ↗
• InjuryOct 6, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 11 MONTHS AFTER THE PRIMARY SURGERY, 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: Unspecified Infection

  MAUDE report 15549325 ↗
• InjurySep 26, 2022Device 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 THE COMPETITOR HEAD AND MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15484047 ↗
• InjuryAug 30, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION PERFORMED 11 MONTHS AFTER THE PRIMARY SURGERY DUE TO INFECTION. LINER AND HEAD REVISED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15320131 ↗
• InjuryAug 3, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE COMPETITOR HEAD FROM THE MEDACTA LINER. THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15154909 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 14250760 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem

  AT 2 MONTHS 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 POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14191710 ↗
• InjuryFeb 28, 2022Device Dislodged or Dislocated

  AT 4 MONTHS AFTER THE PRIMARY, 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. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 13617791 ↗
• InjuryJan 25, 2022Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 13340929 ↗
• InjuryDec 23, 2021Appropriate Device Problem Term/Code Not Available

  AT ONE WEEK AFTER THE PREVIOUS REVISION, 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. THIS IS THE SECOND REVISION SURGERY PERFORMED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13078024 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN 1 MONTH AFTER THE PRIMARY SURGERY 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: Unspecified Infection

  MAUDE report 12999986 ↗
• InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN 1 MONTH 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 AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12983264 ↗
• InjuryNov 10, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 WEEKS 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 12786104 ↗
• InjuryOct 25, 2021Appropriate Device Problem Term/Code Not Available

  ABOUT 1 MONTH AFTER THE PRIMARY SURGERY 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: Unspecified Infection

  MAUDE report 12687963 ↗