Versafitcup CC TRIO Acetabular SystemRecalls & reported problems across all models
Medacta International SA · 32 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 254
- Deaths reported
- 0
- Injuries reported
- 231
- Recalls
- 0
We found 32 models of Versafitcup CC TRIO Acetabular System by Medacta International SA in the FDA's device registry (GUDID). Together they are named in 254 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2017 and Sep 16, 2026 — classified as 231 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (28 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 CC TRIO Acetabular System problems
Device problems
- Appropriate Device Problem Term/Code Not Available75
- Device Dislodged or Dislocated28
- Adverse Event Without Identified Device or Use Problem26
- Loose or Intermittent Connection20
- Osseointegration Problem16
- Device Appears to Trigger Rejection11
- Malposition of Device11
- Loosening of Implant Not Related to Bone-Ingrowth10
Patient problems
- Unspecified Infection53
- Joint Disorder36
- Joint Dislocation23
- Pain20
- Inadequate Osseointegration16
- No Known Impact Or Consequence To Patient16
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available11
- Bone Fracture(s)11
Versafitcup CC TRIO Acetabular System models
32 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Versafitcup CC TRIO Acetabular System 01.26.45.0050Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate23 reports
- Versafitcup CC TRIO Acetabular System 01.26.45.0048Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented21 reports
- Versafitcup CC TRIO Acetabular System 01.26.45.0054Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate20 reports
- Versafitcup CC TRIO Acetabular System 01.26.3244HCTProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented19 reports
- Versafitcup CC TRIO Acetabular System 01.26.45.0052Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented19 reports
- Versafitcup CC TRIO Acetabular System 01.26.3239HCTProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate18 reports
- Versafitcup CC TRIO Acetabular System 01.26.45.0046Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate17 reports
- Versafitcup CC TRIO Acetabular System 01.26.3644HCTProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented15 reports
- Versafitcup CC TRIO Acetabular System 01.26.45.0056Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented13 reports
- Versafitcup CC TRIO Acetabular System 01.26.45.1150Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate12 reports
- Versafitcup CC TRIO Acetabular System 01.26.3648HCTProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate11 reports
- Versafitcup CC TRIO Acetabular System 01.26.2839HCTProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented7 reports
- Versafitcup CC TRIO Acetabular System 01.26.45.1152Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented7 reports
- Versafitcup CC TRIO Acetabular System 01.26.45.0058Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate6 reports
- Versafitcup CC TRIO Acetabular System 01.26.3244HCATProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate5 reports
- Versafitcup CC TRIO Acetabular System 01.26.3244STTProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented5 reports
- Versafitcup CC TRIO Acetabular System 01.26.45.1154Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate5 reports
- Versafitcup CC TRIO Acetabular System 01.26.45.1156Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented5 reports
- Versafitcup CC TRIO Acetabular System 01.26.3248HCTProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 reports
- Versafitcup CC TRIO Acetabular System 01.26.45.0060Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- Versafitcup CC TRIO Acetabular System 01.26.45.0062Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 reports
- Versafitcup CC TRIO Acetabular System 01.26.45.1148Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented3 reports
- Versafitcup CC TRIO Acetabular System 01.26.2837HCTProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Versafitcup CC TRIO Acetabular System 01.26.3248HCATProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Versafitcup CC TRIO Acetabular System 01.26.45.1144Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented2 reports
- Versafitcup CC TRIO Acetabular System 01.26.65.35Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 reports
- Versafitcup CC TRIO Acetabular System 01.26.2839STTProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Versafitcup CC TRIO Acetabular System 01.26.2844HCTProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 report
- Versafitcup CC TRIO Acetabular System 01.26.3244ATProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 report
- Versafitcup CC TRIO Acetabular System 01.26.3652HCTProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Versafitcup CC TRIO Acetabular System 01.26.45.0042Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 report
- Versafitcup CC TRIO Acetabular System 01.26.45.1158Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate1 report
Recent Versafitcup CC TRIO Acetabular System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Loosening of Implant Not Related to Bone-Ingrowth
At 6 months from the primary, the patient came in presenting pain and instability due to a cup that shifted position following primary surgery and the cause is unknown. The surgeon revised the Medacta cup and liner to a competitor cup and liner, and revised the 36mm Biolox Head S to a 36mm BIOLOX Option Head with option sleeve M. The surgery was completed successfully.
Patient problems: Aseptic loosening
MAUDE report 50784461 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
At about 1 month after the primary THR (performed following a femoral fracture due to a fall), revision surgery was performed due to penetration of the acetabular cup and screws through the acetabulum observed on postoperative X-ray. The cup and screws were easily removed using forceps, without a screwdriver. Pelvic reconstruction was performed, followed by implantation of a competitor`s cemented dual-mobility cup and exchange of the Medacta femoral head. Surgery was completed successfully.
Patient problems: Bone Fracture(s)
MAUDE report 50692321 ↗InjuryJul 10, 2026Malposition of Device
PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2026. ON (B)(6) 2026, REVISION SURGERY WAS PERFORMED ON THE LEFT SIDE. ACCORDING TO THE SURGEON, THE REVISION WAS REQUIRED DUE TO INCORRECT POSITIONING OF THE ACETABULAR IMPLANT DURING THE PRIMARY SURGERY, WITH SUBSEQUENT IMPLANT LOOSENING. NO LOOSENING OF THE FEMORAL STEM AND NO INFECTION WERE REPORTED. ALL COMPONENTS WERE EXPLANTED, EXCEPT FOR THE MINIMAX STEM. REIMPLANTATION WAS PERFORMED USING A REINFORCEMENT CAGE, AN APRICOT 44, AND A CRCO BALL HEAD 32 M.
Patient problems: Implant Pain
MAUDE report 25778111 ↗InjuryJul 9, 2026Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY DUE TO A LOOSE CUP AFTER ABOUT 5 YEARS AND 3 MONTHS. THE SURGEON REVISED THE VERSAFITCUP METALBACK CC TRIO D 48 MM TO A MPACT 3D METAL SHELL TWO HOLE D 52MM, REVISED THE FLAT PE HC LINER D 32/C TO A DOUBLE MOBILITY HC LINER D 28/DMC WITH DM CONVERTER, AND REVISED THE 32MM BIOLOX DELTA HEAD M TO A 28MM BIOLOX OPTION HEAD WITH SLEEVE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening
MAUDE report 25763494 ↗InjuryJul 8, 2026Osseointegration Problem
REVISION SURGERY AFTER 6 MONTHS FROM PRIMARY SURGERY DUE TO THE LOOSENING OF THE CUP. THE SURGERY WAS SUCCESSFULLY COMPLETED.
Patient problems: Bone Fracture(s)
MAUDE report 25744802 ↗InjuryMay 26, 2026Device Dislodged or Dislocated
REVISION SURGERY ON DUE TO HIP LUXATION AT ABOUT 3 MONTHS AFTER PRIMARY SURGERY. LINER AND HEAD REVISED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 25275478 ↗InjuryMay 22, 2026Device Appears to Trigger Rejection
THE PATIENT HAD A PRIMARY HIP REPLACEMENT ON (B)(6) 2024. APPROXIMATELY 8 MONTHS AGO, THE PATIENT REPORTED PAIN IN THE RIGHT HIP AREA. INVESTIGATIONS CONFIRMED A PROSTHETIC JOINT INFECTION. ON THE (B)(6) 2026, THE IMPLANTS WERE EXPLANTED, AND A TEMPORARY STEM AND CUP WERE IMPLANTED, WITH PLANNED REVISION SURGERY ONCE THE INFECTION IS RESOLVED. THE ORIGIN OF THE INFECTION IS NOT KNOWN. THE PATIENT HAS MULTIPLE RISK FACTORS (COMORBIDITIES SUCH AS DIABETES AND MORBID OBESITY) THAT MAKE FINDING THE ORIGIN OF THE INFECTION DIFFICULT. THE STEM AND CUP WERE WELL FIXATED, MAKING IMPLANT REMOVAL PROLONGED AND TECHNICALLY DEMANDING.
Patient problems: Medical device site infection
MAUDE report 25253489 ↗InjuryMay 15, 2026Malposition of Device
REVISION SURGERY DUE TO ACETABULAR CUP MALPOSITIONING AFTER ABOUT 1 MONTH FROM PRIMARY. THE ACETABULAR COMPONENTS AND FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH CEMENTED COMPONENTS AND A DUAL MOBILITY BEARING.
Patient problems: Implant Pain
MAUDE report 25185359 ↗InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY AFTER 2 YEARS AND 9 MONTHS DUE TO PAIN. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS SUCCESSFULLY COMPLETED.
Patient problems: Implant Pain
MAUDE report 25123176 ↗InjuryMar 10, 2026Naturally Worn
PRIMARY SURGERY WAS PERFORMED IN 2014. TEN YEARS LATER, THE PATIENT STARTED TO HAVE PAIN, AND ON (B)(6) 2026, THE PATIENT UNDERWENT REVISION SURGERY DUE TOSIGNIFICANT OSTEOLYSIS.
Patient problems: Implant Pain
MAUDE report 24558226 ↗InjuryFeb 24, 2026Device Dislodged or Dislocated
AT ABOUT 2 YEARS 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AS THE RESULT OF A DISLOCATION OF THE HEAD AND LINER AND THE CAUSE IS UNKNOWN. NO TRAUMA IS REPORTED. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 24429829 ↗InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY AT ABOUT 13 YEARS AND 8 MONTHS POST PRIMARY FOR STEM LOOSENING. THE LINER WAS FOUND WORN; IT IS UNKNOWN IF THE LINER WORN CONTRIBUTED TO THE STEM LOOSENING.
Patient problems: Aseptic loosening
MAUDE report 24321110 ↗InjuryDec 23, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY DUE TO SHELL LOOSENING AT 6 MONTHS POST OP.
Patient problems: Aseptic loosening
MAUDE report 23876947 ↗InjuryDec 18, 2025Osseointegration Problem; Osseointegration Problem
AT ABOUT2 YEARS AND 1 MONTHFROM THE PRIMARY, THE PATIENTCAME IN REPORTING PAIN DUE TOLOOSENING OF THE ACETABULAR SHELL. THERE WAS NO LOOSENING OF THE FEMORAL COMPONENT AND NO INFECTION. THE SURGEON REVISED CUP, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Aseptic loosening; Inadequate Osseointegration
MAUDE report 23836925 ↗InjuryNov 21, 2025Migration; Migration
REVISION SURGERY AT ABOUT 8 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERYBECAUSE OF DEVELOPMENT OF BONE GRANULOMA AT ACETABULUM BONE LEVEL. THE SHELL WAS MIGRATED FROM ITS ORIGINAL POSITION. THE ETIOLOGY OF THIS DEVELOPMENT IS UNKNOWN. NO INFECTION DETECTED.
Patient problems: Granuloma
MAUDE report 23615704 ↗
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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