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

Model Number	BI-MENTUM PE LINER 28 / 49
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
It was reported that the infected hip was washed out and debrided.Head and liner were exchanged for new components.There were no deficiencies noted with components.Explanted components are not available for return.Lot numbers were not legible on ceramic head and bimentum head.No surgical delay.Doi: unknown.Dor: (b)(6) 2021.Affected side: unknown.
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.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
Additional information received indicated that the affected side was the left hip.

• Brand Name: BI MENTUM PFRK PE LINER 28 49
• Common Device Name: BI MENTUM LINER
• Manufacturer (Section D): SERF; 85 avenue des bruyères; décines-charpieu 69150 ; FR 69150
• MDR Report Key: 14498858
• Report Number: 1818910-2022-50027
• Device Sequence Number: 5658304
• Product Code: LPH
• UDI-Device Identifier: 03662200015658
• UDI-Public: 03662200015658
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 05/25/2022
• Report Date (Section F): 05/25/2022

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 Model Number: BI-MENTUM PE LINER 28 / 49
• Device Catalogue Number: DS10014928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 06/14/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BI MENTUM PFRK PE LINER 28 49; DLT TS CER HD 12/14 28MM +5.0; PINNACLE DM LINER 56_49
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Date Report Sent to FDA: 05/25/2022