Versafitcup CC TRIO Acetabular System 01.26.3644HCTRecalls & reported problems
Medacta International SA · Flat PE HC liner Ø 36 / E · Class 2 · Implant
All models of Versafitcup CC TRIO Acetabular System (32)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07630030807671), received between Jan 4, 2018 and May 26, 2026 — classified as 15 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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, 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available10
- Device Dislodged or Dislocated4
- Adverse Event Without Identified Device or Use Problem1
- Device Appears to Trigger Rejection1
- Fracture1
Patient problems
- Unspecified Infection6
- Joint Dislocation3
- Insufficient Information2
- Joint Disorder1
- Medical device site infection1
- No Code Available1
- Pain1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
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 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SURGEON REPORTED THAT THE HIP WAS REVISED THE DUE TO PAIN (REASON UNKNOWN) 13 YEARS AFTER PRIMARY SURGERY. THE SHELL AND STEM WERE WELL FIXED, THE VERSAFIT LINER AND BALL HEAD WERE REMOVED AND REPLACED BY A DM CONVERTER, LINER AND A 22MM BALL HEAD. THE CASE WAS COMPLETED SUCCESSFULLY.
Patient problems: Pain
MAUDE report 22094477 ↗InjuryJul 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION SURGERY FOR PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. ONE DAY AFTER THE PRIMARY THE SURGEON REVISED THE HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Dislocation
MAUDE report 19806113 ↗InjuryMay 8, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 8 DAYS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF SURGICAL WOUND ISSUES. IN DETAILS, SEROUS SECRETIONS FROM THE WOUND WERE NOTED. MOBILE COMPONENTS OF THE PROSTHESIS HAVE BEEN REVISED SUCCESSFULLY.
Patient problems: Medical device site infection
MAUDE report 19266722 ↗InjuryAug 3, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PERFORMED AT ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY DUE TO HIP LUXATION. HEAD AND LINER WERE SUCCESSFULLY REVISED FOR A DOUBLE MOBILITY CONVERTER.
Patient problems: Insufficient Information
MAUDE report 15154692 ↗InjuryJan 28, 2022Appropriate Device Problem Term/Code Not Available
AT 1 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER AND HEAD DUE TO INFECTION. DOUBLE MOBILITY IMPLANTED. THE PATIENT PREVIOUSLY UNDERWENT REVISION SURGERY 3 DAYS AFTER THE PRIMARY SURGERY DUE TO PERIPROSTHETIC FRACTURE CAUSED BY A TRAUMA. ONLY STEM REVISED.
Patient problems: Unspecified Infection
MAUDE report 13383495 ↗InjuryNov 22, 2021Fracture; Device Dislodged or Dislocated
AT 2 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY. THE HIP OF THE PATIENT LUXATED (LINER-HEAD). THE PATIENT IS NOT HEALTHY AND LIVES IN A CARE HOME, THE CIRCUMSTANCES AND DATE OF THE LUXATION IS UNKNOWN, IT WAS NOTICED ABOUT 1 WEEK LATER AND THEREFORE THE EXACT CAUSE OF THE LUXATION IS UNKNOWN. THIS IS THE SECOND REVISION FOR THIS PATIENT. PREVIOUSLY THIS PATIENT HAS A STEM REVISION DUE TO A PERIPROSTHETIC FEMORAL FRACTURE CAUSED BY A FALL.
Patient problems: Joint Dislocation
MAUDE report 12852076 ↗InjurySep 7, 2021Appropriate Device Problem Term/Code Not Available
1 YEAR AND 1 MONTH AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 12432603 ↗InjuryAug 3, 2021Appropriate Device Problem Term/Code Not Available
THE PATIENT HAD A WOUND THAT PURGED. 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON RINSED THE WOUND AND REVISED HEAD AND LINER. SURGERY COMPLETED SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 12267570 ↗InjuryApr 7, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY 8 WEEKS AFTER THE PRIMARY DUE TO SUSPECTED INFECTION. DAIR WAS PERFORMED. THE INSERT AND HEAD WERE SUCCESSFULLY REVISED.
Patient problems: Unspecified Infection
MAUDE report 11626180 ↗InjuryOct 27, 2020Appropriate Device Problem Term/Code Not Available
THE PATIENT CAME IN, 6 YEARS AND 11 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY-SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Unspecified Infection
MAUDE report 10738979 ↗InjuryNov 7, 2019Appropriate Device Problem Term/Code Not Available
REVISION FOLLOWING AN INFECTION. MEDACTA LINER AND COMPETITOR'S HEAD HAVE BEEN REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY. PREVIOUS SURGERY DETAILS ARE UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 9289625 ↗InjurySep 5, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY WHERE THE SURGEON WANTS TO CHANGE THE LINER TO A HOODED ONE. AT THE MOMENT NO MORE INFORMATIONS ARE AVAILABLE CONCERNING THE SURGERY DATE AND THE OUTCOMES.
Patient problems: No Code Available
MAUDE report 8964553 ↗InjuryOct 3, 2018Appropriate Device Problem Term/Code Not Available
THE PATIENT UNDERWENT A WASHOUT AND LINER CHANGE DUE TO INFECTION 3 WEEKS AFTER PRIMARY. PATHOGEN INVOLVED: CORYNEBACTERIUM, ENTEROCOCCUS FAECAL, STAPHYLOCOCCUS EPIDERMIS.
Patient problems: Unspecified Infection
MAUDE report 7929609 ↗InjuryJan 4, 2018Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PERFORMED DUE TO MULTIPLE HIP LUXATION ABOUT ONE MONTH AND HALF AFTER PRIMARY. HOODED LINER IMPLANTED.
Patient problems: Joint Disorder
MAUDE report 7163364 ↗
Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices
- BIOLOX DELTA 1365-32-310Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented551 reports
- PINNACLE ALTRX 1221-36-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented481 reports
- BIOLOX DELTA 1365-32-320Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death314 reports
- BIOLOX DELTA 1365-36-720Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 death189 reports
- DJO SURGICAL 400-03-362Encore Medical, L.P. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented187 reports
- Anthology 71365705Smith & Nephew, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented176 reports
- BIOLOX DELTA 1365-40-710Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented170 reports
- PINNACLE GRIPTION 1217-32-054Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented169 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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