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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 02/24/2022

Event Type  Injury  

Event Description

Revision completed due to infection.Doi: (b)(6) 2021.Dor: (b)(6) 2022; affected side: left hip.

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
• Type of Device: 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
• MDR Text Key: 286944205
• Report Number: 1818910-2022-50016
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 03662200015658
• UDI-Public: 03662200015658
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 03/10/2022
• Distributor Facility Aware Date: 02/24/2022
• Date Report to Manufacturer: 02/24/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2022
• Date Device Manufactured: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 59 KG