Versafitcup Double Mobility Shells 01.26.50MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07630030808067), received between Sep 7, 2017 and Mar 10, 2026 — classified as 22 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (5 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Osseointegration Problem

  REVISION DUE TO ACETABULAR CUP LOOSENING ABOUT 12 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY. ECCENTRIC POLYETHYLENE WEAR NOTED.

  Patient problems: Aseptic loosening

  MAUDE report 24558213 ↗
• InjuryJul 16, 2025Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO ACETABULAR CUP MOBILIZATION AND OSTEOLYSIS RELATED TO PE WEAR AT 18 YEARS AFTER PRIMARY.

  Patient problems: Insufficient Information

  MAUDE report 22520977 ↗
• InjuryApr 28, 2025Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY DUE TO LOOSENING AND THE CAUSE IS UNKNOWN. AT ABOUT 5 YEARS AND 7 MONTHS POST PRIMARY 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: Aseptic loosening

  MAUDE report 21916807 ↗
• InjuryDec 2, 2024Osseointegration Problem; Osseointegration Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE CUP AND THE CAUSE IS UNKNOWN. AT 6 YEARS AND 11 MONTHS FROM PRIMARY THE SURGEON REVISED CUP, LINER AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 20817091 ↗
• InjuryMay 13, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 1 YEAR AND 11 MONTHS FROM THE PRIMARY, HIP REVISION SURGERY ON THE RIGHT SIDE DUE TO INFECTION, WHICH CAUSED THE LOOSENING OF THE STEM. EXPLANTATION OF ALL THE COMPONENTS AND REIMPLANTATION OF A M-VIZION STEM 180MM, BODY 20/40MM AND A VERSAFITCUP DM 52 WITH DMF LINER 28 AND CERAMIC BALL HEAD 28 M.

  Patient problems: Unspecified Infection

  MAUDE report 19297228 ↗
• InjuryMar 1, 2023Positioning Problem; Positioning Problem

  REVISION SURGERY WAS PERFORMED AT 10 YEARS AND 6 MONTHS FROM PRIMARY BECAUSE THE CUP WAS NOT WELL POSITIONED IN THE ACETABULUM. THE CUP WAS NOT MOBILIZED. THE SURGEON REVISED THE CUP, HEAD AND LINER SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 16459839 ↗
• InjuryOct 28, 2022Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY AT ABOUT 2 WEEKS AFTER PRIMARY FOR CUP MOBILIZATION. THE REASON OF MOBILIZATION IS UNKNOWN.

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

  MAUDE report 15690002 ↗
• InjuryAug 31, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY AT ABOUT 7 YEARS AND 6 MONTHS POST PRIMARY FOR ACETABULAR BONE FRACTURE, THE STEM WAS WELL FIXED. THE SURGEON REVISED SUCCESSFULLY THE ACETABULAR COMPONENTS AND THE FEMORAL HEAD.

  Patient problems: Bone Fracture(s)

  MAUDE report 15326880 ↗
• InjuryApr 7, 2022Malposition of Device; Appropriate Device Problem Term/Code Not Available

  AT 7 YEARS AND 11 MONTHS AFTER PRIMARY, REVISION SURGERY BECAUSE THE POSITION OF THE CUP WAS BAD. THE REASON OF THIS MALPOSITIONING IS UNKNOWN. ACETABULAR SHELL REVISED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 14040038 ↗
• InjuryDec 23, 2021Osseointegration Problem; Osseointegration Problem

  REVISION SURGERY AT 8 YEARS AND 7 MONTHS AFTER PRIMARY SURGERY DUE TO GROIN PAIN. DURING THE REVISION IT WAS RECOGNIZED THAT THE SHELL WAS LOOSE. THE SURGEON REVISED SUCCESSFULLY THE SHELL, LINER AND HEAD.

  Patient problems: Pain

  MAUDE report 13076749 ↗
• InjuryJul 16, 2021Patient-Device Incompatibility

  6 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO DEVELOPING OSTEOLYSIS AND PAIN. LINER WEAR IS SUSPECTED. THE SURGEON REVISED THE CUP, HEAD, AND LINER AND ADDED A SLEEVE.

  Patient problems: Osteolysis

  MAUDE report 12179338 ↗
• InjurySep 10, 2020Insufficient Device Problem Information

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 2 MONTHS AFTER PRIMARY THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 10513712 ↗
• InjuryJul 20, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING GROIN PAIN DUE TO CUP IMPINGEMENT. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD 6 YEARS AND 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10294918 ↗
• InjuryDec 23, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 WEEKS AFTER PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, LINER, AND CUP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9510720 ↗
• InjuryOct 11, 2019Appropriate Device Problem Term/Code Not Available

  IN THIS COMPLAINT (B)(4) WAS NOT REPORTED THAT METALLOSIS HAS BEEN REVEALED. A FOLLOW-UP TO THE COMPETENT AUTHORITY MUST BE REPORTED. DUE TO THE ROOT CAUSE AND ANALYSIS PERFORMED NO NEW BATCH REVIEW HAS BEEN NECESSARY NOR STATISTICAL ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9179242 ↗
• InjuryJul 25, 2019Loose or Intermittent Connection; Unstable; Appropriate Device Problem Term/Code Not Available

  SECOND REVISION SURGERY PERFORMED FOR CUP LOOSENING ONE WEEK AFTER THE PREVIOUS REVISION SURGERY. THE CUP, LINER AND BALL HEAD HAVE BEEN REVISED. THE FIRST REVISION SURGERY HAS BEEN PERFORMED 3 YEARS AFTER THE PRIMARY SURGERY DUE TO ACETABULUM INSTABILITY (APRICOT CUP MOBILIZATION) AND STEM LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8826041 ↗
• InjuryJul 18, 2019Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(4) WE WERE INFORMED ABOUT A REVISION SURGERY PERFORMED ON (B)(6) ABOUT 1 YEAR AFTER PRIMARY REVISION SURGERY PERFORMED FOR CUP LOOSENING. THE SURGEON BELIEVES THE REASON FOR IMPLANT LOOSENING WAS DUE TO THE PATIENT ANATOMY AND COMBINATION OF MUSCULO-SKELETAL DEFORMITIES. SOME BONDING VISIBLE ON THE RIM OF THE CUP. SOME METALLOSIS VISIBLE DUE TO IMPINGEMENT ON THE TRUNNION OF THE XACTA STEM. CUP, LINER AND HEAD SWAP PERFORMED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8802795 ↗
• InjuryMay 14, 2019Material Protrusion/Extrusion

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2019. UPON REVIEWING THE POST-OP X-RAYS, IT WAS DISCOVERED THAT THE CUP HAD PROTRUDED THROUGH THE MEDIAL WALL DURING IMPACTION. THE SURGEON REVISED, 6 DAYS LATER, THE CUP AND LINER WITH ANOTHER COMPANY'S PRODUCT AND IMPLANTED BONE CHIPS TO PROMOTE BONE GROWTH IN THE ACETABULUM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hip Fracture

  MAUDE report 8607929 ↗
• MalfunctionNov 6, 2018Positioning Failure

  HIP REPLACEMENT WITH A VERSAFIT DM. THE REAMING AND THE TRIAL OF THE CUP WERE DONE, FINALLY, THE CUP VERSAFIT DM Ø 50 WAS CHOSEN AS THE DEFINITIVE CUP; THE IMPLANT WAS COUPLED WITH THE IMPACT RING SIZE 50 WITH ITS MULTIFUNCTIONAL IMPACTOR HANDLE AND THE CUP WAS IMPACTED. WHEN THE IMPACTING RING WAS GOING TO BE DISASSEMBLED FROM THE CUP, THIS PIECE DID NOT LOOSEN; FOR THAT REASON, THE SURGEON HAD TO REMOVE THE CUP WITH THE RELATED IMPACT RING. THE PROCESS WAS REPEATED AND THE SAME SITUATION HAPPENED. THEREFORE, TO POSITION AND IMPACT THE CUP, THE SURGEON USED THE SAME MULTIFUNCTIONAL IMPACTOR HANDLE WITH THE CORRECTION IMPACTION SPHERE Ø 33 FOR METAL BACK (REF. 01.26.10.0017).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8041554 ↗
• InjuryMar 22, 2018Loose or Intermittent Connection

  ON (B)(6) 2018 THE PRODUCT DIRECTOR HIP HAS BEEN INFORMED BY THE SURGEON THAT THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON BELIEVES THE CUP IS LOOSE. THE CAUSE OF THE LOOSENING IS UNKNOWN. THE SURGEON PLANS TO REVISE THE CUP AND LINER WITH ANOTHER COMPANY'S PRODUCT. NO ADDITIONAL INFORMATION IS AVAILABLE. ON (B)(4) 2018 WE WERE INFORMED THAT NO REVISION SURGERY HAS BEEN SCHEDULED YET.

  Patient problems: Joint Disorder

  MAUDE report 7362191 ↗
• InjuryJan 12, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING OF PAIN AND SWELLING ABOUT 4 YEARS AFTER PRIMARY. THE PATIENT HAD A CELL COUNT OF AROUND 2900 (POTENTIAL INFECTION). THE SURGEON REVISED THE CUP, LINER AND HEAD. THE SURGEON USED ANOTHER COMPANY'S CUP AND LINER WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATHOGEN IS UNAVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 7185856 ↗
• InjuryOct 6, 2017Device Slipped

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE CUP WAS LOOSE. THE LOOSENING OCCURRED OVER TIME. THE CUP, LINER AND HEAD WERE REVISED AS PLANNED ON (B)(6) 2017. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder; Pain

  MAUDE report 6921509 ↗
• InjurySep 7, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT PATIENT HAD OSTEOLYSIS AROUND THE CUP. THE SURGEON REMOVED AND REPLACED THE CUP AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE; EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Osteolysis; Pain

  MAUDE report 6847603 ↗

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.