Double Mobility Liner 01.26.2856MRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030807404), received between Nov 23, 2017 and Jan 15, 2021 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2021Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN AFTER 10 YEARS AND 11 MONTHS REPORTING A LEG LENGTH DISCREPANCY (THE CAUSE IS UNKNOWN). THE SURGEON REVISED THE NON-MEDACTA HEAD AND THE MEDACTA LINER WITH A NON-MEDACTA HEAD AND A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 11176028 ↗
• InjuryJan 8, 2021Material Integrity Problem; Material Integrity Problem

  REVISION SURGERY PERFORMED DUE TO OSTEOLYSIS AT THE LEVEL OF THE CUP AND DECENTRALIZATION OF THE HEAD (9 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY). THE POLYETHYLENE WEAR IS SUSPECTED.

  Patient problems: Osteolysis

  MAUDE report 11138876 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PAIN. LINER, HEAD AND ACETABULAR SHELL WERE EXPLANTED ON THE (B)(6) 2019 AND OSTEOLYSIS WAS NOTICED. THE PRIMARY SURGERY PERFORMED ON (B)(6) 2010.

  Patient problems: Osteolysis; Pain

  MAUDE report 9710886 ↗
• InjuryMay 28, 2019Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO STEM LOOSENING 8 YEARS AND 10 MONTHS AFTER PRIMARY. UNQUANTIFIED WEAR OF THE DOUBLE MOBILITY LINER WAS REPORTED (CAUSALITY NOT ESTABLISHED). STEM, LINER AND HEAD HAVE BEEN REVISED. STEM DETAILS ARE NOT AVAILABLE AT THE MOMENT.

  Patient problems: Joint Disorder

  MAUDE report 8645817 ↗
• InjuryNov 23, 2017Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF DISCOMFORT. THE PATIENT PRESENTED WITH OSTEOLYSIS AROUND THE PELVIS, GREATER TROCHANTER AND THE FEMUR. THE SURGEON REVISED THE CUP, LINER, STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Discomfort; Osteolysis

  MAUDE report 7057078 ↗

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.