Versafitcup Double Mobility Shells 01.26.48MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07630030808036), received between Jul 14, 2017 and Jul 21, 2025 — classified as 21 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2025Failure to Osseointegrate; Failure to Osseointegrate

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

  Patient problems: Inadequate Osseointegration

  MAUDE report 22554190 ↗
• InjuryJan 28, 2025Malposition of Device; Malposition of Device

  REVISION FOR MALPOSITIONED CUP AT ABOUT 2 YEARS AND 10 MONTHS POST PRIMARY. THE REASON OF MALPOSITIONED CUP IS UNKNOWN. THE HEAD, LINER AND CUP WERE REVISED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 21250993 ↗
• InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD SHELL IMPINGEMENT WITH SOFT TISSUES AND PAIN IN THE HIP. AT ABOUT 7 YEARS AND 7 MONTHS POST PRIMARY THE SURGEON REVISED THE CUP, HEAD AND LINER. THE ORIGINAL CUP WAS SUSPECTED TO BE TOO LARGE AND POSSIBLY LEADING TO REDUCED RANGE OF MOTION. MEDIALIZED THE NEW CUP IN AN EFFORT TO ALLEVIATE IMPINGEMENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Impingement; Loss of Range of Motion

  MAUDE report 20512688 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. AT ABOUT 13 YEARS AND 11 MONTHS POST PRIMARY THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH A COMPETITOR CUP AND LINER, AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 16633975 ↗
• InjuryMay 24, 2022Appropriate Device Problem Term/Code Not Available

  AT 1 YEAR AND 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14485453 ↗
• InjuryMay 3, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A CUP IMPINGEMENT. THE SURGEON REVISED THE CUP, LINER, AND HEAD 1 YEAR AND 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 14267169 ↗
• InjuryJul 16, 2021Loose or Intermittent Connection

  2 MONTHS AND A HALF 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, LINER, AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12179428 ↗
• InjuryMar 2, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN 4 YEARS 11 MONTHS AFTER THE PRIMARY AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11398506 ↗
• InjuryFeb 16, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 10 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY REPORTING PAIN AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED THE COMPETITOR STEM WITH A COMPETITOR STEM, THE MEDACTA CUP WITH A COMPETITOR CUP, AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 11331088 ↗
• InjuryDec 1, 2020Failure to Align

  THERE WAS A JOINT GEOMETRY ISSUE. MALALIGNMENT OF THE CUP AND LEG LENGTH WAS A BIT SHORT. CUP NEEDED TO BE REVISED TO CORRECT THE JOINT GEOMETRY. CUP, LINER AND HEAD WERE REVISED SUCCESSFULLY 1 YEAR AND 8 MONTHS AFTER PRIMARY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10928295 ↗
• InjuryMar 13, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 10.5 YEARS AFTER PRIMARY SURGERY, FOR A POST-OP APPOINTMENT, AND AFTER TAKING X-RAYS, OSTEOLYSIS OF THE CUP WAS OBSERVED. REVISION SURGERY SUCCESSFULLY COMPLETED.

  Patient problems: Osteolysis

  MAUDE report 9828269 ↗
• InjuryDec 27, 2019Malposition of Device; Malposition of Device

  REVISION SURGERY PERFORMED 1 YEAR AND 9 MONTHS AFTER THE PRIMARY DUE TO IMPINGEMENT (THE CUP WITH THE STEM OR THE LESSER TROCHANTER WITH THE PELVIS). THE CUP WAS ANTEVERTED (THE CAUSE IS UNKNOWN). THE SURGEON REVISED THE HEAD AND LINER. INFECTION NOT PRESENT.

  Patient problems: No Code Available

  MAUDE report 9525226 ↗
• InjuryDec 17, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO PAIN AND IMPINGEMENT 2 YEARS AFTER PRIMARY. THE SHELL WAS ANTEVERTED, NO METALLOSIS HAS BEEN SEEN. THE SHELL CAME OUT RELATIVELY EASILY, A 50 MM G7 WITH DM LINER AND BEARING WERE IMPLANTED AND WE PUT IN +4 SLEEVE WITH 28MM CERAMIC BIOLOX OPTION. IMPINGEMENT WAS CONFIRMED INTRAOPERATIVELY AND THERE WERE SOME MARKS ON THE NECK OF THE FEMORAL COMPONENT THAT WAS LEFT IN PLACE.

  Patient problems: Pain

  MAUDE report 9481017 ↗
• InjuryOct 24, 2019Unintended Movement

  THE PATIENT CAME IN COMPLAINING OF PAIN AND THE CAUSE OF THE PAIN WAS A SHIFTED CUP POST-IMPLANTATION (AFTER 3 YEARS AND 5 MONTHS FROM THE PRIMARY SURGERY), THE ACETABULUM WALL IS NOT FRACTURED. THE SURGEON REVISED THE CUP AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 9233157 ↗
• InjuryApr 3, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 4 WEEKS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN CAUSED BY A FRACTURED ACETABULUM. THE CAUSE OF THE FRACTURE IS UNKNOWN. THE SURGEON REPAIRED THE FRACTURE AND REVISED THE CUP, THE LINER AND THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 8478386 ↗
• InjuryFeb 27, 2019Positioning Problem

  ON JANUARY 31, 2019 WE WERE INFORMED ABOUT THE FACT THAT THE SURGEON WAS NOT PLEASED WITH THE VERTICAL PLACEMENT OF THE CUP AND CONSEQUENTLY WOULD HAVE REVISED THE CUP, HEAD AND LINER ON (B)(6) 2019. THE REVISION WAS PERFORMED AS PLANNED AND WAS COMPLETED SUCCESSFULLY. ACCORDING TO THE SURGEON THE PAIN WAS CAUSED BY THE DM CUP THAT WAS CAUSING IMPINGEMENT OF SOFT TISSUE.

  Patient problems: Pain

  MAUDE report 8374048 ↗
• InjuryFeb 8, 2019Loose or Intermittent Connection

  ABOUT 7 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT CUP, LINER AND CERAMIC HEAD. THE SURGEON SUSPECTED OF CUP LOOSENING BUT WAS NOT CONFIRMED DURING SURGERY. ANYWAY THE SURGEON PERFORMED CUP, LINER AND BALL HEAD SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 8319900 ↗
• InjuryOct 5, 2018Loose or Intermittent Connection

  REVISION SURGERY PERFORMED DUE TO CUP LOOSENING 8 YEARS AND 7 MONTHS. THE SURGEON REVISED THE CUP, HEAD AND LINER.

  Patient problems: Joint Disorder

  MAUDE report 7938069 ↗
• InjuryMar 2, 2018Loose or Intermittent Connection

  ON (B)(6) 2018 MEDACTA INTERNATIONAL HAS BEEN INFORMED BY THE SALES AGENT THAT A PATIENT CAME IN COMPLAINING OF PAIN. THE PAIN MAY BE ATTRIBUTED TO A LOOSE CUP. REVISION SURGERY WILL BE NECESSARY. ON (B)(6) 2018 SURGEON PERFORMED THE REVISION SURGERY.

  Patient problems: Joint Disorder

  MAUDE report 7309092 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON REVISED THE HEAD, CUP AND LINER. ADDITIONAL INFORMATION RECEIVED ON 30 NOV 2017 BY THE COMPLAINER: THERE WAS SMALL EVIDENCE OF OSTEOLYSIS WHICH MOST LIKELY WAS THE CAUSE OF PAIN.

  Patient problems: Joint Disorder; Pain

  MAUDE report 7070540 ↗
• InjuryJul 14, 2017Malposition of Device

  THE PATIENT COMPLAINED OF PAIN. THE SURGEON REVISED THE CUP, HEAD, AND LINER. HE ALSO DETERMINATED THAT THE CAUSE OF PAIN WAS DUE TO THE CUP BEING TOO LATERAL. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Joint Disorder; Pain

  MAUDE report 6714030 ↗

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.