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	Joint Dislocation (2374)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a hip dislocation.The stem, dual mobility liner & head were revised.Reclaim & pinnacle constrained liner were implanted.No surgical delay.Doi: (b)(6) 2023, dor:(b)(6) 2023, affected side: right hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
Additional information received: a.What was the reason for revising the head and the stem? stem was loose due to intra-operative proximal femur fracture.B.Was there any allegation against the head and the stem? no.C.Was there any depuy instrumentation that broke during surgery? if yes, please provide the details.No.
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.

• 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: 16875923
• Report Number: 1818910-2023-150020
• Device Sequence Number: 20266418
• Product Code: LPH
• UDI-Device Identifier: 03662200015658
• UDI-Public: 03662200015658
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/08/2023
• Report Date (Section F): 05/05/2023

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 Model Number: BI-MENTUM PE LINER 28 / 49
• Device Catalogue Number: DS10014928
• Device Lot Number: 2012042A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/02/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/01/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• 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; DELTA CER HEAD 12/14 28MM +5; PINNACLE DM LINER 58_49; SUMMIT DUOFIX TAP SZ6 HI OFF
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Date Report Sent to FDA: 05/05/2023