MAUDE Adverse Event Report: SERF BI MENTUM PFRK PE LINER 28 47

Catalog Number	DS10014728
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.
Event or Problem Description
Patient had a revision surgery for dislocation.Doi: (b)(6) 2022, dor: (b)(6) 2022, affected side : left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.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.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification 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.However, if the product is received at a later date, the investigation will be updated as applicable 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.

• Brand Name: BI MENTUM PFRK PE LINER 28 47
• Common Device Name: PE LINER
• Manufacturer (Section D): SERF; 85 avenue des bruyères; décines-charpieu 69150 ; FR 69150
• MDR Report Key: 20479667
• Report Number: 1818910-2024-150023
• Device Sequence Number: 12851984
• Product Code: LPH
• UDI-Device Identifier: 03662200015641
• UDI-Public: (01)03662200015641
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024
• Report Date (Section F): 10/18/2024

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: DS10014728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/26/2024
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 11/27/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 45 KG
• Date Report Sent to FDA: 10/18/2024