MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 22 43; BI MENTUM LINER

Model Number	BI-MENTUM PE Liner 22,2 / 43
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
It was revised to address wash out (infected).Doi- unknown, dor- (b)(6) 2022, affected side- left hip.

• Brand Name: BI MENTUM PFRK PE LINER 22 43
• Common Device Name: BI MENTUM LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 14021658
• Report Number: 1818910-2022-50019
• Device Sequence Number: 6056658
• Product Code: LPH
• UDI-Device Identifier: 03662200015504
• UDI-Public: 03662200015504
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/06/2022
• Report Date (Section F): 04/06/2022

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 / 43
• Device Catalogue Number: DS10014322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/01/2022
• Date Report to Manufacturer: 04/01/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2022
• 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; BI MENTUM PFRK PE LINER 22 43; PINNACLE DM LINER 50/43
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Date Report Sent to FDA: 04/06/2022