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Double Mobility Liner 01.26.2850MRecalls & reported problems

Medacta International SA · PE Liner 28 / DME · Class 2 · Implant

Data updated Oct 13, 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 07630030807275), received between Dec 7, 2017 and Dec 23, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K083116); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Naturally Worn2
  • Patient-Device Incompatibility1

Patient problems

  • Insufficient Information1
  • Joint Disorder1
  • No Code Available1

Recent adverse event reports

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

  • InjuryDec 23, 2021Naturally Worn

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND THE SURGEON DECIDED TO REVISE THE PATIENT FOLLOWING SUSPECTED LINER WEAR. THE SURGEON REVISED THE COMPETITOR'S HEAD AND MEDACTA POLY 12 YEARS AND 5 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Insufficient Information

    MAUDE report 13078037 ↗
  • InjuryJan 4, 2019Naturally Worn

    DURING A CONSULTATION THE SURGEON DETECTED LINER WEAR. THE REVISION IS NOT SCHEDULED YET. MORE INFO WILL FOLLOW THE CASE.

    Patient problems: No Code Available

    MAUDE report 8217184 ↗
  • InjuryDec 7, 2017Patient-Device Incompatibility

    EIGHT YEARS AFTER PRIMARY THE PATIENT COMPLAINED LEG LENGTH DISCREPANCY. THE SURGEON DETECTED OSTEOSIS DUE TO THE LENGTH DISCREPANCY. THE SURGEON SWAPPED SUCCESSFULLY THE PATIENT HEAD AND LINER.

    Patient problems: Joint Disorder

    MAUDE report 7095378 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083116. One submission often covers many models, so check the product and lot details in each record.

  • Z-2709-2011 · May 23, 2011 · Terminated
    Product Brand Name: Versafitcup Double Mobility Liner Inserter Product Generic Name: Versafitcup Double Mobility Liner Inserter Model Number: 01.26.10.0018 The hip prosthesis is
  • Z-0878-2013 · Jan 15, 2010 · Terminated
    Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.

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

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

Sources and updates

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