MAUDE Adverse Event Report: SERF BI MENTUM PFRK PE LINER 28 49; BI-MENTUM PE LINER

Catalog Number	DS10014928
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/06/2023
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
Clinical notification received for revision due to dislocation.Date of implant: (b)(6) 2022, date of revision: (b)(6) 2023, (left hip).Treatment: head and liner were revised.Revision due to dislocation.The two articulating surfaces are the pinnacle dm liner and bimentum liner, which have been reported for the dislocation.It is reasonable to conclude the revised femoral head did not cause or contribute to the dislocation as it is enclosed within the bimentum liner and does not interact with the articulating surfaces.
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 products were not returned, no product for investigation can be performed.No x ray has been provided, no information.All batches are released in compliance with supplier specifications.Supplier has no evidence to determine the cause of the complaint.Revision leading to implant replacement can be caused by several factors that cannot be demonstrated due to lack of information.Supplier devices involvement is unlikely in these cases.The cause of the problem cannot be confirmed.Supplier will continue to monitor for trends.Device history lot all batches are released in compliance with supplier specifications.

• Brand Name: BI MENTUM PFRK PE LINER 28 49
• Common Device Name: BI-MENTUM PE LINER
• Manufacturer (Section D): SERF; 85 avenue des bruyères; décines-charpieu 69150 ; FR 69150
• MDR Report Key: 17797556
• Report Number: 1818910-2023-150057
• Device Sequence Number: 20255504
• Product Code: MEH
• UDI-Device Identifier: 03662200015658
• UDI-Public: 03662200015658
• 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: 2023
• 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): 09/15/2023
• Report Date (Section F): 09/08/2023

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 Catalogue Number: DS10014928
• Device Lot Number: 2104315A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/03/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• 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: DELTA CER HEAD 12/14 28MM +8.5; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX25MM; PINN MULTIHOLE W/GRIPTION 58MM; PINNACLE DM LINER 58_49; RECLAIM DISTAL TAPERED 15X140; RECLAIM PRX BDY CONE 20X85
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White