MAUDE Adverse Event Report: SERF BI MENTUM PFRK PE LINER 28 47; BI MENTUM LINER

Model Number	BI-MENTUM PE Liner 28 / 47
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).
Event or Problem Description
Patient was revised due to wash out.There was no surgical delay.Doi: unknown.Dor: (b)(6) 2023.Affected side: left hip.

• Brand Name: BI MENTUM PFRK PE LINER 28 47
• Common Device Name: BI MENTUM LINER
• Manufacturer (Section D): SERF; 85 avenue des bruyères; décines-charpieu 69150 ; FR 69150
• MDR Report Key: 16395556
• Report Number: 1818910-2023-150007
• Device Sequence Number: 17792632
• Product Code: LPH
• UDI-Device Identifier: 03662200015641
• UDI-Public: 03662200015641
• 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: 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): 02/17/2023
• Report Date (Section F): 02/17/2023

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 Model Number: BI-MENTUM PE Liner 28 / 47
• Device Catalogue Number: DS10014728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/01/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 47; DELTA CER HEAD 12/14 28MM +5
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Date Report Sent to FDA: 02/17/2023