MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 28 53; BIMENTUM LINER

Model Number	BI-MENTUM PE LINER 28 / 53
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised due to infection.Doi: (b)(6) 2021, dor: (b)(6) 2021, affected side: left hip.

• Brand Name: BI MENTUM PFRK PE LINER 28 53
• Common Device Name: BIMENTUM LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 13002059
• Report Number: 1818910-2021-50048
• Device Sequence Number: 11982789
• Product Code: LPH
• UDI-Device Identifier: 03662200015672
• UDI-Public: 03662200015672
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 12/14/2021
• Report Date (Section F): 12/14/2021

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 / 53
• Device Catalogue Number: DS10015328
• Device Lot Number: 1907031A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/18/2021
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/10/2022
• 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: BI MENTUM PFRK PE LINER 28 53
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Date Report Sent to FDA: 12/14/2021