Versafitcup CC TRIO Acetabular System 01.26.45.1156Recalls & reported problems
Medacta International SA · Versafitcup Metalback CC Trio No-hole Ø56 mm · 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030807916), received between Aug 3, 2017 and Dec 4, 2024 — classified as 5 injuries.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).
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 Available2
- Device Appears to Trigger Rejection1
- Inadequacy of Device Shape and/or Size1
- Osseointegration Problem1
Patient problems
- Unspecified Infection2
- Inadequate Osseointegration1
- Joint Disorder1
- Pain1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 4, 2024Osseointegration Problem; Osseointegration Problem
REVISION SURGERY DUE TO STEM AND CUP LOOSENING, AT ABOUT 10 YEARS AFTER PRIMARY. ALL COMPONENTS SUCCESSFULLY REVISED. PRIMARY SURGERY DATE UNKNOWN.
Patient problems: Inadequate Osseointegration
MAUDE report 20843583 ↗InjuryMar 16, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection
AT ABOUT 1 YEAR 5 MONTHS AFTER THE PRIMARY, REVISION SURGERY PERFORMED DUE TO INFECTION. THE SURGEON REVISED SUCCESSFULLY ALL COMPONENTS.
Patient problems: Unspecified Infection
MAUDE report 16553137 ↗InjurySep 29, 2020Appropriate Device Problem Term/Code Not Available
HIP REVISION SURGERY 5 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY DUE TO PAIN AND INSTABILITY FEELING WHILE THE PATIENT WALKING DUE TO CUP ANTEVERSION. ALL THE IMPLANTS HAVE BEEN REMOVED SUCCESSFULLY AND COMPETITOR'S PRODUCTS IMPLANTED.
Patient problems: Pain
MAUDE report 10599607 ↗InjuryOct 24, 2018Inadequacy of Device Shape and/or Size
ABOUT 2 YEARS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP BECAUSE THE CUP IMPLANTED IN PRIMARY SURGERY WAS TOO BIG. THE SIZE 56 CUP WAS REPLACED WITH A SIZE 52; THE LINER AND THE HEAD WERE SWAPPED, TOO. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Joint Disorder
MAUDE report 7999373 ↗InjuryAug 3, 2017Appropriate Device Problem Term/Code Not Available
FOR AN INFECTION THE SURGEON REVISED SUCCESSFULLY THE CUP, THE LINER AND THE HEAD 1 MONTH AFTER PRIMARY. NO IMPLANTS AVAILABLE. THE PATHOGEN IS NOT AVAILABLE.
Patient problems: Unspecified Infection
MAUDE report 6763334 ↗
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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