MAUDE Adverse Event Report: SERF BI MENTUM PFRK PE LINER 22 41; HIP LINER IMPLANT

Catalog Number	DS10014122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).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 was revised due to impingement.Doi: (b)(6) 2023.Dor: (b)(6) 2024.Affected side: left hip.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary:although distributed by medtech orthopaedics, 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 orthopaedics 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: on 09/09/2024, answer was sent to serf: ¿regarding (b)(4)., below information has been received from sales rep: -no information was received from sales representative after three follow ups.So, please proceed without the sample.¿ documentary review: review of the manufacturing file for bi-mentum liner 22.2/41: batch 2012091a: (b)(4).Units from manufacturing order no.Of (b)(4).Were produced in april 2021.Dimensional and roughness controls comply with serf specifications.The manufacturing file was checked for conformity by the release department on 06/11/2021.No anomalies were found in the of file.No other complaints were reported for this batch.Technical investigation: due to the absence of the device, it was not possible to carry out a technical investigation.The manufacturing data complies with supplier specifications.No additional information has been provided to determine the cause of the impingement or to confirm whether the supplier implant was the cause of the issue.As a result, the cause of the impingement could neither be demonstrated nor determined.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 : review of the manufacturing file for bi-mentum liner 22.2/41: batch 2012091a: (b)(4).Units from manufacturing order no.Of(b)(4).Were produced in april 2021.

• Brand Name: BI MENTUM PFRK PE LINER 22 41
• Common Device Name: HIP LINER IMPLANT
• Manufacturer (Section D): SERF; 85 avenue des bruyères; décines-charpieu 69150 ; FR 69150
• MDR Report Key: 19972809
• Report Number: 1818910-2024-150017
• Device Sequence Number: 20573898
• Product Code: LPH
• UDI-Device Identifier: 03662200015498
• UDI-Public: (01)03662200015498(17)260531(10)2012091A
• 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: 2023
• Device Explanted Year: 2024
• 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): 08/13/2024
• Report Date (Section F): 08/13/2024

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 Expiration Date: 05/31/2026
• Device Catalogue Number: DS10014122
• Device Lot Number: 2012091A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/12/2024
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARTICUL/EZE BALL 22.225+4 NK; PFC SIGMARP STB TB IN 2.5 10.0; PINN CAN BONE SCREW 6.5MMX30MM; PINN CAN BONE SCREW 6.5MMX30MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Date Report Sent to FDA: 08/13/2024