MAUDE Adverse Event Report: SERF BI MENTUM PFRK PE LINER 28 61; BI MENTUM LINER

Catalog Number	DS10016128
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented with an infected hip.The femoral head was removed and replaced.Original date of surgery was unknown but mentioned (b)(6) 2024 at an unknown facility.Doi: (b)(6) 2024, dor: (b)(6) 2025, affected side: right hip.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d10.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary- no device associated with this report was received for examination.Although distributed by depuy synthes 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 depuy synthes customer quality complaint management system.Per the supplier agreement, the supplier is responsible for any corrective actions identified during the complaint investigation process.An evaluation of the manufacturing record could not be performed as the required lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary- although distributed by depuy synthes 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 depuy synthes 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: an event regarding infection involving bi-mentum liner was reported.The event was not confirmed.All the supplier products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Additional information including pathology reports, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.As part of depuy synthes 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 lot number is unknown; therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.Corrected: h8.

• Brand Name: BI MENTUM PFRK PE LINER 28 61
• Common Device Name: BI MENTUM LINER
• Manufacturer (Section D): SERF; 85 avenue des bruyères; décines-charpieu 69150 ; FR 69150
• MDR Report Key: 22522290
• Report Number: 1818910-2025-150011
• Device Sequence Number: 7950996
• Product Code: LPH
• UDI-Device Identifier: 03662200015719
• UDI-Public: (01)03662200015719
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/29/2025

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: DS10016128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/22/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 07/24/2025; 08/26/2025; 12/29/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARTICULEZE HD CER 28 +5; BI MENTUM PFRK PE LINER 28 61
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female