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Double Mobility Liner 01.26.2244MHCRecalls & reported problems

Medacta International SA · HC PE Liner 22 / DMB · Class 2 · Implant

All models of Double Mobility Liner (20)

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

Adverse event reports
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030806803), received between Apr 20, 2018 and Nov 10, 2023 — classified as 4 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: 1 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: 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

  • Device Appears to Trigger Rejection2
  • Appropriate Device Problem Term/Code Not Available1
  • Device Dislodged or Dislocated1

Patient problems

  • Unspecified Infection3
  • Dizziness1
  • Fall1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 10, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER THAT THE PATIENT SUSTAINED WHILE DANCING. THE SURGEON REVISED THE HEAD AND LINER AND 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 AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Unspecified Infection

    MAUDE report 18111194 ↗
  • InjuryFeb 23, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    AT ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT CAME PRESENTING INFLAMED TISSUES DUE TO INFECTION. THE SURGEON REVISED SUCCESSFULLY THE HEAD AND LINER.

    Patient problems: Unspecified Infection

    MAUDE report 16427658 ↗
  • InjuryMar 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

    REVISION SURGERY PERFORMED 7 MONTHS AFTER THE PRIMARY SURGERY DUE TO INTRA-PROSTHETIC DISLOCATION BETWEEN THE COCR HEAD AND THE HIGH CROSS DOUBLE MOBILITY LINER. PREVIOUSLY THE PATIENT FELL AFTER A DIZZY SPELL IN (B)(6) 2020 AND INCURRED A PELVIC FRACTURE. A CLOSE REDUCTION OF THE HIP WAS PERFORMED AT THAT MOMENT. AFTER THE REVISION SURGERY, THE HEAD WAS COUPLED WITH THE LINER AGAIN AND TRIED TO REMOVE IT BY HAND, BUT IT WAS NOT POSSIBLE. THE IMPLANTS WERE THOROUGHLY WASHED AND LEFT IN ALCOHOL FOR AN HOUR SINCE STERILIZATION WAS NOT POSSIBLE TO BE PERFORMED.

    Patient problems: Dizziness; Fall

    MAUDE report 11503405 ↗
  • InjuryApr 20, 2018Appropriate Device Problem Term/Code Not Available

    THREE DAYS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A HIP INFECTION IMPLANTING A SPACER MADE BY: MASTERLOC STEM, COCR HEAD, CEMENTING MPACT LINER AND USING A COMPETITOR SPACER FOR THE ACETABULUM. ON THE (B)(6) 2018 THE SURGEON SWAPPED THE SPACED WITH DEFINITIVE IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY

    Patient problems: Unspecified Infection

    MAUDE report 7446814 ↗

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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