Double Mobility Liner 01.26.2854MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030807374), received between Nov 15, 2017 and May 6, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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

• InjuryMay 6, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO PAIN ABOUT 14 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY. SIGNS OF OSTEOLYSIS WERE NOTED AROUND THE PROXIMAL FEMUR. IT IS UNKNOWN IF THE LINER WAS WORN.

  Patient problems: Osteolysis

  MAUDE report 19249217 ↗
• InjuryMay 27, 2021Appropriate Device Problem Term/Code Not Available

  LEFT HIP REVISION PERFORMED ON (B)(6) 2021 (9 YEARS AND 2 MONTHS AFTER PRIMARY) FOLLOWING SUSPECTED POLYETHYLENE WEAR AND ACUTE OSTEOLYSIS (PAPROSKY STAGE 2) OF THE ACETABULUM AND THE FEMORAL PROXIMAL PART. ONLY THE LINER, THE CUP VERSAFICUP, AND THE INOX HEAD HAVE BEEN REMOVED, THE QUADRA STEM WAS LEFT IN PLACE. THE REVISION WENT WELL.

  Patient problems: Osteolysis

  MAUDE report 11893141 ↗
• InjuryNov 15, 2017Inadequacy of Device Shape and/or Size

  THE PATIENT CAME IN COMPLAINING OF A LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7032801 ↗

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.