Versafitcup Double Mobility Shells 01.26.46MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030808012), received between Dec 21, 2017 and May 30, 2025 — 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. How this data works · Data updated Oct 13, 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 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 YEARS AND 11 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND IT WAS NOTICED IMPINGEMENT BETWEEN NECK AND FEMUR WITH THE CUP/ACETABULUM. MOREOVER, SOME HETEROTOPIC OSSIFICATION BETWEEN FEMUR AND ACETABULUM WERE NOTICED. THE SURGEON REVISED THE MEDACTA CUP, HEAD AND LINER TO COMPETITOR COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 22113329 ↗
• InjuryApr 2, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 7 YEARS AND 7 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE MEDACTA CUP AND LINER WITH A COMPETITOR CUP AND LINER AND REVISED THE MEDACTA HEAD WITH A NEW MEDACTA HEAD.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19018319 ↗
• InjurySep 1, 2022Osseointegration Problem; Osseointegration Problem

  AT ABOUT 3 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD.

  Patient problems: Pain

  MAUDE report 15335950 ↗
• InjuryDec 7, 2018Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE OF PAIN WAS DUE TO IRRITATION OF THE PSOAS CAUSED BY THE VERSAFIT DM CUP BEING TOO LARGE FOR THE PATIENTS ANATOMY. THE SURGEON BURRED THE EDGE OF THE DM CUP TO BETTER FIT THE PATIENTS ANATOMY AND REVISED THE LINER WITH ANOTHER COMPANY'S PRODUCT. THE SURGEON REVISED THE HEAD WITH A MEDACTA HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8141702 ↗
• InjuryDec 21, 2017Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE CUP WAS LOOSE. THE CAUSE OF THE LOOSENING IS UNKNOWN. THE PATIENT DID NOT EXPRESS ANY TRAUMA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7137287 ↗

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.