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

Catalog Number	DS5050153
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	08/21/2024
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.The following devices were also listed in this report: rm52280065 ds50001565 bi mentum rk screw 5 65; cat# rm52280065; lot# 1808124a.Rm52260153 ds10015328 bi mentum rk pe liner 28 53; cat# rm52260153; lot# 1909319a.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
(b)(4): (b)(6) it was reported that patient was revised due to infection.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Reported event: an event regarding infection (leading to revision) involving a bi mentum rk plus cup 53 was reported.Investigation conclusions: bi-mentum plus cup 53 -> lot - batch n° 1902177a.Manufacturing order (b)(4) units.Week: 16 / 17 cleaning date: 16.04.2019.Packaging: 16.04.2019.Sterilization date: 22.04.2019 ¿ order (b)(4).Technical investigation: since the devices have not been returned to serf, a technical investigation is not feasible.The investigation will therefore be conducted based on the records available for the batches concerned and the monitoring records over the production period of the batches concerned.Documentary investigation: for the batches of devices, the final cleaning ensuring decontamination does not present any anomaly.This is compliant with the validated cycle.¿ batch 1902177a: program 2 metal carried out on 16/04/2019.Compliant parameters.For the batches of devices, the primary packaging ensuring the maintenance of the sterile state after sterilization does not present any anomaly.This is compliant with the validated cycles.¿ batch 1902177a: heat sealing ¿120¿ carried out on 16/04/2019.Compliant parameters.For the batches of devices, the sterilization step does not present any anomaly.The results are in line with expectations.¿ batch 1902177a: order=(b)(4) of 19/04/2019.Treatment (b)(6) of 22/04/2019.Compliant parameters.Overall conclusion: the manufacturing steps ensuring the cleanliness and sterility of the devices do not present any deviations likely to compromise the cleanliness or sterility of the products.

• Brand Name: BI-MENTUM PLUS CUP 53
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL / POLYMER, NON-POROUS, CALC
• 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: 21230739
• Report Number: 3008668801-2025-00076
• Device Sequence Number: 20727453
• Product Code: MEH
• UDI-Device Identifier: 03662200015153
• UDI-Public: 03662200015153
• 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): 02/25/2026

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 Expiration Date: 03/31/2024
• Device Catalogue Number: DS5050153
• Device Lot Number: 1902177A
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2019
• 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