Skip to content

Mpact Acetabular System 01.32.152MHRecalls & reported problems

Medacta International SA · Acetabular shell Ø52 Multi-hole · Class 2 · Implant

All models of Mpact Acetabular System (68)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
8
Deaths reported
0
Injuries reported
8
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07630030810800), received between May 16, 2018 and Nov 5, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available2
  • Osseointegration Problem2
  • Adverse Event Without Identified Device or Use Problem1
  • Failure to Osseointegrate1
  • Loose or Intermittent Connection1
  • Malposition of Device1

Patient problems

  • Unspecified Infection3
  • Inadequate Osseointegration2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Aseptic loosening1
  • Joint Disorder1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 5, 2025Osseointegration Problem; Osseointegration Problem

    AT 4 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON DETERMINED THE PATIENT HAD ASEPTIC LOOSENING OF THE CUP. THE REVISION WAS COMPLETED USING COMPETITOR CUP, AUGMENTS, AND MODULAR DUAL MOBILITY CONSTRUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Aseptic loosening

    MAUDE report 23477175 ↗
  • InjuryMay 9, 2023Failure to Osseointegrate; Failure to Osseointegrate

    AT ABOUT 1 YEAR AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE CUP, HEAD AND LINER.

    Patient problems: Inadequate Osseointegration

    MAUDE report 16893410 ↗
  • InjuryApr 26, 2023Osseointegration Problem; Osseointegration Problem

    REVISION SURGERY AT 25 DAYS FROM PRIMARY SURGERY DUE TO CUP LOOSENING. ACETABULAR COMPONENTS WERE REVISED SUCCESSFULLY.

    Patient problems: Inadequate Osseointegration

    MAUDE report 16813625 ↗
  • InjuryFeb 23, 2022Appropriate Device Problem Term/Code Not Available

    THE PRIMARY HIP SURGERY ON (B)(6) 2020. 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 CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, AT 7 MONTHS FROM THE PRECEDENT SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP, LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Unspecified Infection

    MAUDE report 13584648 ↗
  • InjuryFeb 17, 2022Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY PERFORMED 2 YEARS AND 8 MONTHS DUE TO INFECTION. ALL IMPLANTS REMOVED AND SPACER IMPLANTED.

    Patient problems: Unspecified Infection

    MAUDE report 13548449 ↗
  • InjuryMay 20, 2021Malposition of Device; Malposition of Device

    PRIMARY PERFORMED IN (B)(6) 2021. POST-OP X-RAYS REVEALED A MALPOSITIONED CUP. IN (B)(6) 2021 THE SURGEON SUCCESSFULLY REVISED THE CUP, LINER, AND HEAD.

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

    MAUDE report 11854201 ↗
  • InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem

    WASHOUT PERFORMED AFTER 2 MONTHS FROM THE PRIMARY DUE TO SIGNS OF AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND DID NOT EXPLANT ANY IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Unspecified Infection

    MAUDE report 9376095 ↗
  • InjuryMay 16, 2018Loose or Intermittent Connection

    ABOUT 10 DAYS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A CUP LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY IMPLANTING A LARGER CUP.

    Patient problems: Joint Disorder

    MAUDE report 7518547 ↗

Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented devices

All Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page