Versafitcup Double Mobility Shells 01.26.58MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030808203), received between Nov 24, 2017 and May 13, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Slipped” (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.

• InjuryMay 13, 2026Malposition of Device

  AT 1 YEAR 9 MONTHS FROM MEDACTA PRIMARY SURGERY, THE PATIENT PRESENTED WITH PAIN. PROBABLE ILIOPSOAS IMPINGEMENT WAS SUSPECTED DUE TO A SLIGHTLY OVERHANGING ACETABULAR CUP. THERE WAS NO EVIDENCE OF COMPONENT LOOSENING OR INFECTION. THE SURGEON REVISED THE MEDACTA CUP AND DM LINER WITH A REINFORCEMENT CAGE (SIZE 62) WITH SCREWS, VERSACEM 56 CUP AND DMH LINER.

  Patient problems: Implant Pain

  MAUDE report 25160331 ↗
• InjurySep 3, 2020Difficult to Remove

  THE SURGEON WANTED TO IMPLANT A VERSAFITCUP DM S58 AND AFTER HE HAD A PRESS-FIT THE IMPACTING RING DID NOT COME OFF. BY TRYING SEVERAL TIMES AFTERWARD ALSO WITH A VERSAFITCUP CC TRIO HE HAD TO CEMENT A NEW ONE- APRICOT. THE BONE STRUCTURE WAS DAMAGED. THE SURGEON CEMENTED A NEW CUP ON THE BONE DAMAGE.

  Patient problems: No Code Available

  MAUDE report 10487424 ↗
• InjuryAug 5, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A MIGRATED CUP THAT AROSE FROM POOR FIXATION 10 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE CUP AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10366569 ↗
• InjuryFeb 28, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AFTER ONE MONTH AND HALF FROM THE PRIMARY DUE TO SIGNS OF INFECTION (PATHOGEN UNKNOWN). THE CUP AND LINER HAVE BEEN EXPLANTED (AN ANTIBIOTIC SPACER WAS IMPLANTED). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8377329 ↗
• InjuryNov 24, 2017Device Slipped

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE CUP WAS LOOSE. THE SURGEON REVISED THE CUP, THE LINER AND THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder; Pain

  MAUDE report 7057482 ↗

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.