MAUDE Adverse Event Report: S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION BI-MENTUM PE LINER 28/53; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	DS10015328
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	07/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
(b)(4): (b)(6) patient was revised due to infection.
Event or Problem Description
No new information.On (b)(4): serf rc-23-0124 patient was revised due to infection.
Additional Manufacturer Narrative
Investigation conclusion : an event regarding infection (leading to revision) involving a bi mentum rk pe liner 28 53 was reported.The reported device is a serf product.The products were not returned, no product for investigation can be performed.No x ray has been provided, no information.All batches are released in compliance with serf specifications.Serf has no evidence to determine the cause of the complaint.Revision leading to implant replacement can be caused by several factors that cannot be demonstrated due to lack of information.Serf devices involvement is unlikely in these cases.The cause of the problem cannot be confirmed.

• Brand Name: BI-MENTUM PE LINER 28/53
• 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, FL 69150 ; FR 69150 ; 9546280700
• MDR Report Key: 21230738
• Report Number: 3008668801-2025-00077
• Device Sequence Number: 7578330
• Product Code: MEH
• UDI-Device Identifier: 03662200015511
• UDI-Public: 03662200015511
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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 Expiration Date: 01/31/2026
• Device Catalogue Number: DS10015328
• Device Lot Number: 2009434A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2021
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown