MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 28 51; BI MENTUM LINER

Model Number	BI-MENTUM PE Liner 28 / 51
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).
Event or Problem Description
Patient was revised due to chronic infection.Removal of all implants took place.Doi: (b)(6) 2023, dor: (b)(6) 2023, affected side: left hip.

• Brand Name: BI MENTUM PFRK PE LINER 28 51
• Common Device Name: BI MENTUM LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 16777449
• Report Number: 1818910-2023-150016
• Device Sequence Number: 15200442
• Product Code: LPH
• UDI-Device Identifier: 03662200015665
• UDI-Public: 03662200015665
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 04/20/2023
• Report Date (Section F): 04/20/2023

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 Expiration Date: 09/30/2024
• Device Model Number: BI-MENTUM PE Liner 28 / 51
• Device Catalogue Number: DS10015128
• Device Lot Number: 1907298A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/17/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2019
• 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 51.; DLT TS CER HD 12/14 28MM +12.; PINN CAN BONE SCREW 6.5MMX15MM.; PINN CAN BONE SCREW 6.5MMX15MM.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN CAN BONE SCREW 6.5MMX20MM.; PINN CAN BONE SCREW 6.5MMX25MM.; PINN CAN BONE SCREW 6.5MMX30MM.; PINN MULTIHOLE W/GRIPTION 60MM.; PINNACLE DM LINER 60_51.; RECLAIM DISTAL TAPERED 18X240A.; RECLAIM PRX BDY CONE 24X105.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Date Report Sent to FDA: 04/20/2023