MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 BI MENTUM PFRK PE LINER 28 49; BI MENTUM LINER

Model Number	BI-MENTUM PE Liner 28 / 49
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision completed due to infection.Doi: (b)(6) 2021.Dor: (b)(6) 2022; affected side: left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BI MENTUM PFRK PE LINER 28 49
• Common Device Name: BI MENTUM LINER
• Manufacturer (Section D): DEPUY INT'L LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 13721305
• Report Number: 1818910-2022-50016
• Device Sequence Number: 5883147
• Product Code: LPH
• UDI-Device Identifier: 03662200015658
• UDI-Public: 03662200015658
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K071830
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 03/10/2022
• Report Date (Section F): 03/10/2022

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
• Device Lot Number: 1909307A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/24/2022
• Date Report to Manufacturer: 02/24/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2022
• Date Device Manufactured: 04/03/2020
• 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: APEX HOLE ELIM POSITIVE STOP; DELTA CER HEAD 12/14 28MM +1.5; PINN CAN BONE SCREW 6.5MMX20MM; PINN CAN BONE SCREW 6.5MMX35MM; PINN MULTIHOLE W/GRIPTION 58MM; PINNACLE DM LINER 58_49
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Date Report Sent to FDA: 03/10/2022