Versafitcup Double Mobility Shells 01.26.52MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07630030808098), received between Aug 18, 2017 and Aug 3, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Fracture

  Revision at 5 days from primary surgery for bone fracture. The reason of fracture is unknown. The shell was found in a different position from the primary, likely as a secondary effect of the fracture. Shell, liner, and head revised successfully.

  Patient problems: Bone Fracture(s)

  MAUDE report 50114135 ↗
• InjuryMay 12, 2026Osseointegration Problem

  REVISION DUE TO CUP LOOSENING AFTER ABOUT 10 YEARS AND 2 MONTHS FROM PRIMARY. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE MEDACTA CUP AND LINER TO A COMPETITOR CUP AND LINER AND REVISED THE MEDACTA 28MM COCR HEAD XXL TO A D 28 BIOLOX OPTION HEAD WITH SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 25148967 ↗
• InjuryMar 31, 2025Osseointegration Problem; Osseointegration Problem

  ABOUT 9 YEARS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE OF THE LOOSE CUP IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21729100 ↗
• InjuryDec 2, 2024Osseointegration Problem; Osseointegration Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. AT ABOUT 10 YEARS AND 6 MONTHS POST-PRIMARY THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20819778 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 7 YEARS AND 8 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A CUP IMPINGEMENT WITH THE TRUNNION OF THE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA CUP AND LINER TO COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD TO A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 18756832 ↗
• InjuryOct 18, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 6 YEARS AND 9 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 15623331 ↗
• InjuryApr 13, 2022Appropriate Device Problem Term/Code Not Available

  IMPLANTS REMOVED ABOUT 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY DURING STAGE 1 REVISION DUE TO SUSPECTED INFECTION, IMPLANTS REMOVED AND SPACER IMPLANTED. STAGE 2 (PERMANENT IMPLANT) WILL FOLLOW.

  Patient problems: Unspecified Infection

  MAUDE report 14099758 ↗
• InjuryFeb 7, 2022Osseointegration Problem; Osseointegration Problem

  AT 4 YEARS 9 MONTHS AFTER THE 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 CUP AND LINER TO COMPETITORS AND REVISED THE MEDACTA HEAD TO A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 13469122 ↗
• InjuryFeb 24, 2020Naturally Worn

  THE PATIENT CAME IN REPORTING PAIN, AND THE SURGEON OBSERVED THAT THE PATIENT'S POSTERIOR WALL WAS WORN AWAY AFTER ABOUT 11 YEARS FROM THE PRIMARY SURGERY. THE SURGEON REPLACED THE POSTERIOR WALL, ADDED AN AUGMENT AND REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 9744766 ↗
• InjuryJul 15, 2019Loose or Intermittent Connection

  FOR CUP LOOSENING THE SURGEON, ABOUT 4 YEARS AFTER PRIMARY, REVISED THE PATIENT CERAMIC HEAD, LINER AND SHELL. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8789419 ↗
• InjuryJul 11, 2019Patient-Device Incompatibility

  REVISION SURGERY PERFORMED AFTER 7 YEARS FROM THE PRIMARY DUE TO PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE HEAD, CUP, AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 8780218 ↗
• InjuryJun 6, 2019Loose or Intermittent Connection

  ON (B)(6) 2019 WE WERE INFORMED ABOUT A REVISION SURGERY PERFORMED ON THE FOLLOWING DAY, AFTER ABOUT 12 YEARS FROM THE PRIMARY, DUE TO CUP LOOSENING AND LUXATION OF THE HEAD FROM THE LINER. NO INFORMATION ABOUT THE HEAD, IF CERAMIC OR CRCO.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8673857 ↗
• InjuryJan 18, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PAIN CAUSED BY IRRITATION OF THE PSOAS TENDON. THE SURGEON REVISED THE HEAD WITH A MEDACTA HEAD. THE CUP AND THE LINER WERE REVISED WITH ANOTHER COMPANY PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Irritation; Pain

  MAUDE report 8260590 ↗
• InjuryJun 25, 2018Loose or Intermittent Connection

  REVISION DUE TO ASEPTIC LOOSENING OF THE CUP 10 YEARS AFTER PRIMARY SURGERY; THE PATIENT REPORTED ABOUT LIMPING AND PAIN.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 7633540 ↗
• InjuryMar 22, 2018Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY CASE ON (B)(6) 2015. ON (B)(6) 2017 THE PATIENT CAME IN COMPLAINING OF INSTABILITY DUE TO STEM SUBSIDENCE. THE SURGEON REVISED THE PATIENT WITH ANOTHER COMPANY'S STEM AND HEAD AND A MEDACTA LINER [(B)(4)]. ON (B)(6) 2018 THE PATIENT CAME IN COMPLAINING OF PAIN. THE CAUSE IS UNKNOWN. THE SURGEON REMOVED THE CUP (IMPLANTED ON (B)(6) 2015) AND THE LINER (IMPLANTED ON (B)(6) 2017) AND THE OTHER COMPANY'S HEAD WITH ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 7360998 ↗
• InjuryJan 3, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE INFECTION IS CONFIRMED AS RARE BETA HEMOLYTIC STREPTOCOCCI. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED A SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7160289 ↗
• InjuryAug 18, 2017Device Dislodged or Dislocated

  REVISION DUE TO LUXATION OF DOUBLE MOBILITY HIP (LUXATION OF INLAY FROM THE CUP & THE HEAD FROM THE INLAY).

  Patient problems: Joint Dislocation

  MAUDE report 6803639 ↗

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.