MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 22 45

Model Number	BI-MENTUM PE Liner 22,2 / 45
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient converted from pinnacle dm to constrained liner, chronic dislocater.Explanted dm liner, pe liner and head.There is no reported loosening.There is no reported surgical delay.Doi: (b)(6) 2022.Dor: (b)(6) 2022.Affected side: left.

• Brand Name: BI MENTUM PFRK PE LINER 22 45
• Common Device Name: BI MENTUM PFRK PE LINER 22 45
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 14717815
• Report Number: 1818910-2022-50033
• Device Sequence Number: 2135506
• Product Code: KWY
• UDI-Device Identifier: 03662200015511
• UDI-Public: 03662200015511
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2022
• Report Date (Section F): 06/16/2022

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 22,2 / 45
• Device Catalogue Number: DS10014522
• Device Lot Number: 2009428A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/03/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2022
• 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: ARTICUL/EZE BALL 22.225+4 NK; PINNACLE DM LINER 52_45
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 06/16/2022