MAUDE Adverse Event Report: S.E.R.F SOCIETE DETUDES RECHERCHE FABRICATION RM52260151 DS10015128 BI MENTUM RK PE LINER 28 51; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number	UNK_JSE
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Insufficient Information (4580)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4): (b)(6) the patient was revised due to pain and instability.Unknown surgical delay.
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.
Additional Manufacturer Narrative
Reported event : an event regarding infection (leading to revision) involving a bi mentum rk pe liner was reported.Conclusions : the reported device is an serf product.Investigation : "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.".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
Correction of the event: patient was revised due to infection.Unknown surgical delay.Doi: (b)(6) 2023 dor: unknown.Affected side: left hip.

• Brand Name: RM52260151 DS10015128 BI MENTUM RK PE LINER 28 51
• 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: 21230148
• Report Number: 3008668801-2025-00056
• Device Sequence Number: 8302133
• Product Code: MEH
• UDI-Device Identifier: 03662200015665
• UDI-Public: 03662200015665
• 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): 01/21/2026

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: 05/31/2026
• Device Catalogue Number: UNK_JSE
• Device Lot Number: 2012073A
• 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: 11/30/2023
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2021
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown