Versafitcup Double Mobility Shells 01.26.60MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030808234), received between Feb 20, 2019 and Sep 26, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2022Loss of Osseointegration; Loss of Osseointegration

  AT ABOUT 12 YEARS AND 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP WITH A COMPETITOR CUP AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15483907 ↗
• InjuryFeb 20, 2019Loose or Intermittent Connection

  THE PATIENT CAME IN DUE TO INSTABILITY CAUSED BY A LOOSE CUP 10 YEARS AFTER PRIMARY. THE SURGEON REVISED THE CUP, LINER AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8353653 ↗

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.