MAUDE Adverse Event Report: SERF BI MENTUM PFRK PE LINER 22 45

Catalog Number	DS10014522
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
J&j medtech is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which j&j medtech has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, j&j medtech or its employees that the report constitutes an admission that the device, j&j medtech, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient was having trouble with stability/dislocations despite correctly positioned implants.Surgeon removed dual mobility construct and put a constrained construct in.Doi: (b)(6) 2023, dor: (b)(6) 2025, affected side: left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: although distributed by medtech orthopedics joint reconstruction, the product is designed, manufactured, and labeled by the manufacturing supplier.The requirement of fda reporting, complaint investigation, root cause, and corrective action is the responsibility of the designing supplier of this item, per the supplier agreement.The product/information will be transferred to the supplier with the complaint problem statement for investigation.The results of the supplier investigation are to be populated into the medtech orthopedics customer quality complaint management system.Per the supplier agreement, the supplier is responsible for any corrective actions identified during the complaint investigation process.The following investigation was provided by the supplier legal manufacturer: technical investigation: the technical investigation cannot be carried out because the device has not been returned.Documentary review: article: pfrm52260045a // of 123738 004.The device was manufactured by serf in 2020 ((b)(4) units).The manufacturing steps ensuring the cleanliness and the sterility of the device are complaint with defined specifications (cleaning ensuring contamination, vacuum and heat sealing carried out 26/10/2020 and sterilization carried out 30/10/2020).No non-conformance observed for this batch.Release by serf was established on 30/10/2020 ((b)(4) units).At the time of being placed on the market, the device was compliant.No other complaints have been recorded on this batch.Conclusion: in the absence of technical investigation and based on the documentary review, the cause of the problem cannot be established.As part of medtech orthopedics quality process all devices are manufactured, inspected, and released to approved specifications.No further investigation with regard to this complaint is required.The supplier will continue to monitor for trends.Device history lot: the device was manufactured by serf in 2020 ((b)(4) units).The manufacturing steps ensuring the cleanliness and the sterility of the device are complaint with defined specifications (cleaning ensuring contamination, vacuum and heat sealing carried out 26/10/2020 and sterilization carried out 30/10/2020).No non-conformance observed for this batch.Release by serf was established on 30/10/2020 ((b)(4) units).At the time of being placed on the market, the device was compliant.

• Brand Name: BI MENTUM PFRK PE LINER 22 45
• Common Device Name: BI MENTUM PFRK PE LINER 22 45
• Manufacturer (Section D): SERF; 85 avenue des bruyères; décines-charpieu 69150 ; FR 69150
• MDR Report Key: 22292351
• Report Number: 1818910-2025-150008
• Device Sequence Number: 21055922
• Product Code: LPH
• UDI-Device Identifier: 03662200015511
• UDI-Public: (01)03662200015511(17)250930(10)2002660A
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: DS10014522
• Device Lot Number: 2002660A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/04/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2021
• 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
• Patient Age: 66 YR
• Patient Sex: Female