Versafitcup Double Mobility Shells 01.26.54MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07630030808128), received between Jul 7, 2017 and Nov 6, 2024 — classified as 18 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (3 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2024Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 15 YEARS AND 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20618352 ↗
• InjuryOct 10, 2023No Apparent Adverse Event; No Apparent Adverse Event

  REVISION FOR ACETABULUM BONE FRACTURE AT ABOUT 12 YEARS AND 1 MONTH POST PRIMARY SURGERY. VERSAFITCUP DM, LINER AND HEAD REVISED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 17904520 ↗
• InjuryAug 9, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 9 YEARS 7 MONTHS AFTER TEH PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP WITH A COMPETITOR CUP AND REVISED THE MEDACTA HEAD AND LINER WITH A NEW MEDACTA HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17489440 ↗
• InjuryJun 16, 2023Osseointegration Problem; Osseointegration Problem

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2011 ON (B)(6) 2017, THE PATIENT CAME IN COMPLAINING OF A LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO LOOSENED CUP AND THE CAUSE IS UNKNOWN. THE SURGEON 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: Implant Pain

  MAUDE report 17142662 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE LINER (11MM TO 13 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17134717 ↗
• InjuryMar 15, 2023Osseointegration Problem; Osseointegration Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. AT ABOUT 7 YEARS AND 11 MONTHS POST-PRIMARY THE SURGEON 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: Inadequate Osseointegration

  MAUDE report 16546153 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 9 YEARS 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING GROIN PAIN AND ILIOPSOAS TENDONITIS. THE SURGEON REVISED THE CUP THAT WAS LOOSE, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration; Inflammation

  MAUDE report 16546023 ↗
• InjuryFeb 24, 2023Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 10 YEARS AND 7 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE AND UNSTABLE 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: Inadequate Osseointegration

  MAUDE report 16435290 ↗
• InjuryMar 30, 2022Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT HAD PRIMARY HIP SURGERY ON (B)(6) 2013. ON (B)(6) 2017, THE PATIENT CAME IN REPORTING PAIN. THE SURGEON NOTICED THAT THE PATIENT HAD OSTEOLYSIS AND REVISED HEAD AND LINER. PRESENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP. THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Osteolysis; Pain

  MAUDE report 13949937 ↗
• InjuryAug 28, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS (ONLY LINER AND CUP ARE MEDACTA'S PRODUCTS) AND IMPLANTED AN ANTIBIOTIC SPACER 5 YEARS AND 3 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10464399 ↗
• InjuryNov 18, 2019Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A LOOSE CUP THAT WAS CAUSED FROM OSTEOLYSIS. THE SURGEON REVISED THE CUP, LINER, AND HEAD ALMOST 10 YEARS AND 5 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9334637 ↗
• InjuryJun 14, 2019Malposition of Device; Malposition of Device

  REVISION SURGERY PERFORMED 8 YEARS AND 7 MONTHS AFTER PRIMARY DUE TO HIP PAIN AND TIGHTNESS. DURING THE REVISION SURGERY THE STEM AND THE CUP WERE WELL FIXED, THE LINER AND THE BALL HEAD HAVE BEEN REVISED AS STANDARD PROCEDURE. THE IMAGES PROVIDED SHOW A MALPOSITIONED AND OVERSIZED CUP, AND IT IS CONCEIVABLE, BASED ON THE SCARCE INFORMATION SUPPLIED, THAT THE ORIGIN OF PAIN IS THE LATERALLY PROTRUDING CUP.

  Patient problems: Pain

  MAUDE report 8699969 ↗
• InjuryApr 11, 2019Loose or Intermittent Connection

  ABOUT 9 YEARS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR CUP LOOSENING. CUP, HEAD AND LINER SWAP. THE SURGERY WAS PERFORMED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8503597 ↗
• InjuryMar 29, 2019Appropriate Device Problem Term/Code Not Available

  INDEPENDENT SALES AGENT DID NOT HAVE THE IMPLANTS AVAILABLE FOR THE CASE WHICH CAUSED A DELAY IN THE OR. THE SURGEON DECIDED TO INTRAOPERATIVELY REPOSITION THE ACETABULAR CUP AFTER HE HAD IMPLANTED ALL THE COMPONENTS. TO WORK ON THE CUP, THE SURGEON HAD TO EXPLANT THE LINER AND FEMORAL HEAD. THE AGENT DID NOT HAVE A SECOND INVENTORY BANK AND HAD TO GET THE REPLACEMENT LINER AND HEAD FROM ANOTHER HOSPITAL. WE THINK THIS CAUSED A 20 - 30 MINUTE DELAY IN THE CASE.

  Patient problems: Joint Disorder

  MAUDE report 8464672 ↗
• InjuryMay 2, 2018Loose or Intermittent Connection

  REVISION SURGERY AFTER 1 YEAR AND 10 MONTHS FROM THE PRIMARY DUE TO CUP LOOSENING.

  Patient problems: Joint Disorder

  MAUDE report 7479653 ↗
• InjuryFeb 16, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY HIP ON (B)(6) 2017. THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE CAUSE WAS UNKNOWN. DURING REVISION, THE SURGEON DETERMINED THE PATIENT WAS INFECTED. THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7276204 ↗
• InjuryNov 15, 2017Device Slipped

  TWELVE YEARS AFTER PRIMARY SURGERY THE SURGEON DETECTED A CUP LOOSENING AND REVISED THE PATIENT SWAPPING SUCCESSFULLY ALL THE JOINT IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7032799 ↗
• InjuryJul 7, 2017Malposition of Device; Malposition of Device

  THE PATIENT CAME IN COMPLAINING OF DISCOMFORT. THE SURGEON DETERMINED THAT THE CUP WAS MALPOSITIONED. PRIMARY X-RAYS ARE NOT AVAILABLE. THE SURGEON REVISED THE CUP, LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 6692850 ↗

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.