Versafitcup Double Mobility ShellsRecalls & reported problems across all models
Medacta International SA · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 103
- Deaths reported
- 0
- Injuries reported
- 102
- Recalls
- 0
We found 9 models of Versafitcup Double Mobility Shells by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 103 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2017 and Aug 3, 2026 — classified as 102 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (15 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Versafitcup Double Mobility Shells problems
Device problems
- Appropriate Device Problem Term/Code Not Available24
- Loose or Intermittent Connection15
- Osseointegration Problem15
- Adverse Event Without Identified Device or Use Problem14
- Malposition of Device8
- Device Dislodged or Dislocated4
- Device Slipped3
- Failure to Osseointegrate3
Patient problems
- Pain28
- Inadequate Osseointegration17
- Joint Disorder16
- Unspecified Infection13
- Bone Fracture(s)6
- Implant Pain6
- Osteolysis5
- No Known Impact Or Consequence To Patient4
Versafitcup Double Mobility Shells models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Versafitcup Double Mobility Shells 01.26.50MBProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate23 reports
- Versafitcup Double Mobility Shells 01.26.48MBProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate21 reports
- Versafitcup Double Mobility Shells 01.26.54MBProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate18 reports
- Versafitcup Double Mobility Shells 01.26.52MBProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate17 reports
- Versafitcup Double Mobility Shells 01.26.56MBProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate10 reports
- Versafitcup Double Mobility Shells 01.26.46MBProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate5 reports
- Versafitcup Double Mobility Shells 01.26.58MBProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate5 reports
- Versafitcup Double Mobility Shells 01.26.60MBProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 reports
- Versafitcup Double Mobility Shells 01.26.62MBProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 reports
Recent Versafitcup Double Mobility Shells adverse event reports
The 15 most recent reports across all models, 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 13, 2026Malposition of Device
AT 1 YEAR 9 MONTHS FROM MEDACTA PRIMARY SURGERY, THE PATIENT PRESENTED WITH PAIN. PROBABLE ILIOPSOAS IMPINGEMENT WAS SUSPECTED DUE TO A SLIGHTLY OVERHANGING ACETABULAR CUP. THERE WAS NO EVIDENCE OF COMPONENT LOOSENING OR INFECTION. THE SURGEON REVISED THE MEDACTA CUP AND DM LINER WITH A REINFORCEMENT CAGE (SIZE 62) WITH SCREWS, VERSACEM 56 CUP AND DMH LINER.
Patient problems: Implant Pain
MAUDE report 25160331 ↗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 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 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 ↗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 ↗InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AT ABOUT 5 YEARS AND 11 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND IT WAS NOTICED IMPINGEMENT BETWEEN NECK AND FEMUR WITH THE CUP/ACETABULUM. MOREOVER, SOME HETEROTOPIC OSSIFICATION BETWEEN FEMUR AND ACETABULUM WERE NOTICED. THE SURGEON REVISED THE MEDACTA CUP, HEAD AND LINER TO COMPETITOR COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Implant Pain
MAUDE report 22113329 ↗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 ↗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 ↗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 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 ↗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 ↗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 ↗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 ↗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 ↗
Other Medacta International SA products
- GMK Sphere Total Knee System209 models · 2,306 reports
- GMK Primary Total Knee System99 models · 876 reports
- Shoulder System63 models · 716 reports
- AMIStem H Femoral Stems20 models · 679 reports
- Mpact Acetabular System68 models · 609 reports
- Mectacer Biolox Delta Femoral Ball Head15 models · 551 reports
- Quadra H femoral stems32 models · 354 reports
- MectaLIF Anterior6 models · 4 reports · 6 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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