Versafitcup Double Mobility Shells 01.26.56MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630030808173), received between Nov 24, 2017 and Jan 31, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (2 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2025Loss of Osseointegration; Loss of Osseointegration

  AT 11 YEARS AND 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD, CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 21282428 ↗
• InjuryJan 14, 2025Osseointegration Problem; Osseointegration Problem

  THE PATIENT HAD PAIN DUE TO A LOOSE CUP. AT ABOUT 14 YEARS AND 10 MONTHS POST PRIMARY THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH A COMPETITOR'S IMPLANTS AND REVISED THE MEDACTA HEAD WITH ANOTHER MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 21147020 ↗
• InjuryJul 24, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 14 YEARS AND 9 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND OSTEOLYSIS AND A LOOSE ACETABULAR COMPONENT HAVE BEEN DETECTED. THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE HEAD, CUP AND LINER.

  Patient problems: Inadequate Osseointegration; Osteolysis

  MAUDE report 19814527 ↗
• InjuryApr 26, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 13 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A FRACTURED ACETABULUM AND THE CAUSE IS UNKNOWN. THE SURGEON PLATED THE FRACTURE, REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 16814939 ↗
• InjuryDec 9, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY AT ABOUT 10 YEARS AND 11 MONTHS AFTER PRIMARY DUE TO HIP INFECTION. AN ANTIBIOTIC SPACER HAS BEEN IMPLANTED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12968415 ↗
• InjuryAug 12, 2019Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH INFECTED HIP 6 WEEKS POST OP. SURGEON HAS EXPLANTED PROSTHESIS TO TREAT INFECTION WITH ANTIBIOTIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 8883098 ↗
• InjuryJul 30, 2019Appropriate Device Problem Term/Code Not Available

  SECOND REVISION SURGERY PERFORMED AFTER 3 MONTHS FROM THE FIRST REVISION DUE TO AN INFECTION(THE PATHOGEN IS UNKNOWN). THE CUP AND THE LINER HAVE BEEN REVISED SUCCESSFULLY. THE FIRST REVISION SURGERY HAS BEEN PERFORMED AFTER 4 MONTHS FROM THE PRIMARY ALSO DUE TO AN INFECTION. (PATHOGEN UNKNOWN). THE SURGEON PERFORMED THE WASHOUT AND REVISED ANOTHER COMPANY'S HEAD AND LINER WITH MEDACTA PRODUCTS.

  Patient problems: Unspecified Infection

  MAUDE report 8841175 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem

  ABOUT 6 YEARS AFTER PRIMARY REVISION SURGERY FOR CUP/STEM IMPINGEMENT. THE SURGEON REVISED THE PATIENT CUP, STEM, LINER AND CERAMIC HEAD.

  Patient problems: Joint Disorder

  MAUDE report 8514352 ↗
• InjuryMar 21, 2019Loose or Intermittent Connection

  ON (B)(6) 2019, WE WERE ALERTED OF A REVISION SURGERY PLANNED ON (B)(6) 2019 DUE TO AN UNKNOWN REASON. ON (B)(6) 2019 WE RECEIVED THE INFORMATION THAT THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY VIA POSTERIOR APPROACH, THE MAIN REASON WAS CUP LOOSENING. THE FEMORAL STEM WAS FOUND TO BE IN GOOD POSITION AND SOLIDLY INGROWN WITHIN THE FEMUR. THE ACETABULAR COMPONENT WAS LOOSE AND EASILY REMOVED, THERE WAS A SMALL AMOUNT OF BONE ATTACHED TO THE POLAR REGION OF THE CUP AND THIS LEFT A HOLE IN THE MEDIAL WALL OF THE ACETABULUM. THE ACETABULUM WAS PREPARED FOR TWO AUGMENTS THAT WERE SCREWED INTO PLACE, CUP WAS POSITIONED OVER THESE AUGMENTS AND BONE GRAFT, THEN CEMENTED AND SCREWED INTO POSITION. A DOUBLE MOBILITY LINER WAS CEMENTED INTO THE CUP, PRIOR TO THE 28MM CERAMIC OPTION HEAD BEING PLACED WITHIN THE POLYETHYLENE HEAD. THE HIP WAS REDUCED AND CLOSED, THE PATIENT LEG LENGTH WAS LONGER DUE TO THE EXTENSIVE ACETABULAR RECONSTRUCTION ABOVE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8439902 ↗
• InjuryNov 24, 2017Device Dislodged or Dislocated

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE CUP HAD SHIFTED. THE SURGEON PLANS TO REVISE THE CUP, LINER AND HEAD.

  Patient problems: Joint Disorder; Pain

  MAUDE report 7057436 ↗

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.