Versafitcup Double Mobility Shells 01.26.62MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030808265), received between Oct 23, 2019 and Feb 24, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2021Malposition of Device; Malposition of Device

  THE PATIENT CAME IN REPORTING PAIN DUE TO MALPOSITIONING OF THE CUP. THE CAUSE OF THE MALPOSITIONED CUP IS UNKNOWN. THE SURGEON REVISED ALL THE COMPONENTS WITH COMPETITOR HARDWARE 10 YEARS 11 MONTHS AFTER THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11371451 ↗
• InjuryOct 23, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN 5 MONTHS AFTER PREVIOUS SURGERY, THE CAUSE OF THE PAIN WAS A TORN TENDON. THE SURGEON PERFORMED AN ABDUCTOR TENDON REPAIR AND REVISED THE CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD A FIRST REVISION SURGERY IN (B)(6) 2018 PERFORMED DUE TO HIP DISLOCATION AND A SECOND REVISION IN (B)(6) 2019.

  Patient problems: Pain

  MAUDE report 9224548 ↗

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.