BI-MENTUM Cemented Cup BI-MENTUM Cemented Cup 51Recalls & reported problems
Soc Etudes Recherches Fabrication · BI-MENTUM dual mobility system - BI-MENTUM Cemented Cup metal-back cemented · Class 2 · Implant
All models of BI-MENTUM Cemented Cup (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03662200015429), received between Aug 27, 2024 and Dec 5, 2025 — classified as 8 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Adverse Event Without Identified Device or Use Problem6
- Loosening of Implant Not Related to Bone-Ingrowth1
- Patient Device Interaction Problem1
- Unstable1
Patient problems
- Joint Laxity3
- Pain3
- Pelvic Pain2
- Inadequate Osseointegration1
- Joint Dislocation1
- Unspecified Tissue Injury1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT OCCURED A CUP REVISION ON THE RIGHT HIP DUE TO PAIN.
Patient problems: Pelvic Pain
MAUDE report 23726384 ↗InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI- UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE- RIGHT HIP.
Patient problems: Pain
MAUDE report 23606221 ↗InjurySep 23, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN DOR: (B)(6) 2025 AFFECTED SIDE: RIGHT HIP.
Patient problems: Pain
MAUDE report 23030719 ↗InjuryJul 31, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
PATIENT OCCCURED A LOOSENING AT UNKNOWN INTERFACE.
Patient problems: Inadequate Osseointegration
MAUDE report 22680524 ↗InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
UPON FURTHER REVIEW, THE PREVIOUSLY REPORTED EVENT WAS DETERMINED TO HAVE OCCURRED IN NEW ZEALAND AND THEREFORE DOES NOT MEETING REPORTING REQUIREMENTS AS AN IMPORTER. THIS DOES NOT MEET THE DEFINITION OF A COMPLAINT AND THEREFORE PLEASE DISREGARD ANY FURTHER REPORTS ON 1818910-2025-150001.
Patient problems: Joint Dislocation; Joint Laxity; Unspecified Tissue Injury
MAUDE report 21696083 ↗InjuryDec 3, 2024Unstable; Unstable
IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INSTABILITY. NO BROKEN INSTRUMENT, NO DELAYS.
Patient problems: Joint Laxity
MAUDE report 20829976 ↗InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INSTABILITY. THERE WAS NO HARM, NO BROKEN INSTRUMENT, NO DELAYS. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.
Patient problems: Joint Laxity
MAUDE report 20078295 ↗
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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