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Versacem Acetabular Shell and Double Mobility HC Liners 01.26.2846MHCRecalls & reported problems

Medacta International SA · Double Mobility HC Liner Ø28/DMC · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630542703928), received between Mar 30, 2026 and Jul 6, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 18, 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: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 1 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

  • Device Appears to Trigger Rejection2
  • Device Dislodged or Dislocated1

Patient problems

  • Medical device site infection2
  • Joint Dislocation1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 6, 2026Device Dislodged or Dislocated

    REVISION SURGERY DUE TO A DISLOCATION OF THE DM LINER FROM THE DM CONVERTER LINER AFTER ABOUT 1 MONTH FROM PRIMARY. THE SURGEON REVISED THE MEDACTA CUP, LINER, DM CONVERTER AND HEAD TO COMPETITOR DEVICES.

    Patient problems: Joint Dislocation

    MAUDE report 25714727 ↗
  • InjuryMay 5, 2026Device Appears to Trigger Rejection

    THE PATIENT HAD INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH POST THE SURGEON PERFORMED A WASHOUT AND REVISED THE D 28/DMC LINER TO A SAME SIZE LINER AND REVISED THE 28MM BIOLOX HEAD L TO A SAME SIZE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Medical device site infection

    MAUDE report 25077221 ↗
  • InjuryMar 30, 2026Device Appears to Trigger Rejection

    REVISION SURGERY WAS PERFORMED APPROXIMATELY 10 DAYS AFTER THE PRIMARY SURGERY DUE TO AN ACUTE JOINT INFECTION OF UNKNOWN ORIGIN.THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Medical device site infection

    MAUDE report 24711032 ↗

Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices

All Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices →

Sources and updates

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