Versafitcup CC TRIO Acetabular System 01.26.65.35Recalls & reported problems
Medacta International SA · Cancellous bone screw flat head Ø 6,5 L35 · Class 2
All models of Versafitcup CC TRIO Acetabular System (32)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030808357), received between Sep 19, 2018 and May 22, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Insert” (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.
Most reported problems
Device problems
- Difficult to Insert1
- Fracture1
Patient problems
- Foreign Body In Patient1
- No Code Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2019Fracture; Fracture
CANCELLOUS BONE SCREW FLAT HEAD BROKE DURING THE PROCESS OF ADJUSTING THE SCREW. THE BODY OF THE SCREW REMAINED IN THE ACETABULUM AND IT WAS NOT POSSIBLE TO TAKE IT OUT. THE SURGEON REVIEWED THAT NO PART OF THE BODY OF THE SCREW WAS OUT, AVOIDING SOME TOUCH / RUB WHEN THE LINER HC UHMWPE WAS IMPLANTED. THE SURGERY COMPLETED SUCCESSFULLY, THE BODY OF THE SCREW WAS WELL SEATED.
Patient problems: Foreign Body In Patient
MAUDE report 8631622 ↗InjurySep 19, 2018Difficult to Insert
DURING AN AMIS SURGERY THE SURGEON WAS NOT BE ABLE TO PUT A SECOND SCREW TO FIX A VERSAFIT CUP CC TRIO. THE BONE WAS SCLEROTIC. HE TRIED TO FIX IT FOR 15 MIN BUT HE WAS NOT ABLE TO SCREW AND ENTER IN THE BONE, EVEN IF HE HAD DRILLED THE HOLE AND HAD USED THE INSTRUMENT GUIDE ACCORDING THE PROCEDURES. HE DECIDED TO LEAVE ONE SCREW ONLY AS HE COMMENTED IT WAS ENOUGH FIX THE CUP.
Patient problems: No Code Available
MAUDE report 7888908 ↗
Other Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate devices
- Novation 130-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls156 reports
- Novation 130-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls79 reports
- CORAIL 3L92511Depuy (Ireland) · Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate158 reports
- Acumatch A Series 138-36-29Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate3 recalls1 report
- Novation 136-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls43 reports
- Novation 130-32-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls33 reports
- Novation 132-32-51Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls26 reports
- Novation 136-36-53Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate2 recalls22 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.
How reports and recalls are matched · Editorial policy · Report an error on this page