MAUDE Adverse Event Report: SERF BI MENTUM PFRK PE LINER 28 51; BI MENTUM PE LINER

Catalog Number	DS10015128
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient presented with infection so removed all implants to allow for infection to clear.It was unknown about surgical delay.Doi: (b)(6) 2023, dor: unknown, affected side: left hip.
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.

• Brand Name: BI MENTUM PFRK PE LINER 28 51
• Common Device Name: BI MENTUM PE LINER
• Manufacturer (Section D): SERF; 85 avenue des bruyères; décines-charpieu 69150 ; FR 69150
• MDR Report Key: 18138842
• Report Number: 1818910-2023-150063
• Device Sequence Number: 8045526
• Product Code: LZO
• UDI-Device Identifier: 03662200015665
• UDI-Public: 03662200015665
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2023
• Report Date (Section F): 11/06/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: DS10015128
• Device Lot Number: 2012073A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/01/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• 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: DLT TS CER HD 12/14 28MM +1.5; PINN CAN BONE SCREW 6.5MMX30MM; PINN SECTOR W/GRIPTION 60MM; PINNACLE DM LINER 60_51; RECLAIM MON REV STD STEM 18 SO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male