MAUDE Adverse Event Report: S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION BI-MENTUM CEMENTED CUP 47; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	DS4901147
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
(b)(6) school of engineering at (b)(6) first report of retrievals for statement of work 10 for q4 of 2024.(b)(6) is the research location, and not the facility of placement.A competitor implant was revised and reviewed for analysis reason for revision: revision due to acetabular bone fracture and loosening of a bimentum cup.No additional information will be provided by (b)(6).
Event or Problem Description
(b)(6) first report of retrievals for statement of work 10 for q4 of 2024.(b)(6) is the research location, and not the facility of placement.A competitor implant was revised and reviewed for analysis reason for revision: revision due to acetabular bone fracture and loosening of a bimentum cup.No additional information will be provided by (b)(6).
Additional Manufacturer Narrative
Manufacturer entity d3 corrected to s.E.R.F societe detudes recherche fabrication.
Additional Manufacturer Narrative
Reported event: an event regarding a periprosthetic fracture (leading to revision) involving a bi mentum pfrk cem cup 47 was reported.Conclusions: the reported device is an serf product.Technical investigation the technical investigation cannot be carried out because the device has not been returned.Documentary investigation of: 127502 002 - 50 units manufactured no non-compliance observed on this batch a complaint (b)(4) was recorded on this batch regarding the patient's review following pain: after investigation, the complaint did not call into question the product's quality.The checks carried out during manufacturing demonstrate the dimensional compliance of the devices.50 units placed on the market by (b)(4) in october 2022 device compliance at the time of its market release no knowledge of the devices associated with the cup in the absence of further information: cause cannot be confirmed, no problem detected corrective action/preventive action: no action is required by stryker at this time as the investigation for this event is performed by serf.
Event or Problem Description
(b)(4) at (b)(4) first report of retrievals for statement of work 10 for q4 of 2024.(b)(4) is the research location, and not the facility of placement.A competitor implant was revised and reviewed for analysis reason for revision: revision due to acetabular bone fracture and loosening of a bimentum cup.No additional information will be provided by (b)(4).

• Brand Name: BI-MENTUM CEMENTED CUP 47
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION; 85 avenue des bruyeres; 69150 decines-charpieu; decines NJ 69150 ; FR 69150
• Manufacturer (Section G): S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION; 85 avenue des bruyeres; 69150 decines-charpieu; decines 69150 ; FR 69150
• Manufacturer Contact: jean-denys marechal ; 85 avenue des bruyeres; 69150 decines-charpieu; decines, NJ 69150 ; FR 69150 ; 2018315000
• MDR Report Key: 21100499
• Report Number: 3008668801-2025-00002
• Device Sequence Number: 8818514
• Product Code: LZO
• UDI-Device Identifier: 03662200015405
• UDI-Public: 03662200015405
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DS4901147
• Device Lot Number: 2206204A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 01/24/2025; 01/24/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 01/24/2025; 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown