BI-MENTUM PressFit Cup BI-MENTUM PressFit Cup 51Recalls & reported problems
Soc Etudes Recherches Fabrication · BI-MENTUM dual mobility system - BI-MENTUM PressFit Cup metal-back cementless BI-MENTUM PressFit Cup version is available without the pegs and screw, and is a press fit only · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03662200014996), received between May 27, 2025 and May 27, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Malposition of Device” (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
- Malposition of Device1
Patient problems
- Bone Fracture(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2025Malposition of Device; Malposition of Device
IN THE ABSENCE OF INFORMATION ALLOWING TRACEABILITY OF DEFECTIVE PRODUCTS, THE DOCUMENT REVIEW CANNOT BE CARRIED OUT. THE PRE/POST-REVISION X-RAYS SHOW A REPLACEMENT OF THE IMPLANTS AND IN PARTICULAR AN ANCHORING OF THE ACETABULUM WITH HOOK AND SCREW DURING THE REVISION, CONFIRMING THE REVISION. THE PATIENT OCCURED A FRACTURE OF THE CALCAR AS WELL AS A POSITIONING OF THE ACETABULUM "TOO MEDIAL" WITH A PROTRUDING HOLE IN THE SMALL PELVIS. THE UNDERSTANDING THAT CAN BE MADE OF THIS IS A DEFECT IN THE POSITIONING OF THE ACETABULUM. HOWEVER, THE INFORMATION PROVIDED IS INSUFFICIENT TO CONFIRM OR REFUTE THIS HYPOTHESIS.
Patient problems: Bone Fracture(s)
MAUDE report 22089030 ↗
Other Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium 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.
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