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

Catalog Number	DS45320147
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised for infection.Affected side: right hip.
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.
Additional Manufacturer Narrative
Update of the catalog number in section d4.Correction of 510k number in section g4.Update combination product in section g4 to "no".Investigation conclusion : the technical investigation cannot be carried out because the device has not been returned.The documentary review cannot be carried out because the lot number has not been communicated.In the absence of information, the cause of the problem cannot be confirmed.
Event or Problem Description
No new information.

• Brand Name: BI-MENTUM PRESSFIT CUP 47
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• Manufacturer (Section D): S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION; 85 avenue des bruyeres; 69150 decines-charpieu; decines 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: 21729600
• Report Number: 3008668801-2025-00090
• Device Sequence Number: 4222809
• Product Code: MEH
• UDI-Device Identifier: 03662200014972
• UDI-Public: 03662200014972
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K181744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: DS45320147
• Device Lot Number: UNKNOWN
• 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: 03/05/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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