MAUDE Adverse Event Report: SERF 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	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that head & liner exchange due to infection.New head and liner implanted.No further information available.Doi: (b)(6) 2022, dor: (b)(6) 2022, affected side: left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).

• Brand Name: BI MENTUM PFRK PE LINER 28 51
• Common Device Name: BI MENTUM LINER
• Manufacturer (Section D): SERF; 85 avenue des bruyères; décines-charpieu 69150 ; FR 69150
• MDR Report Key: 15240548
• Report Number: 1818910-2022-50040
• Device Sequence Number: 6447436
• Product Code: LPH
• UDI-Device Identifier: 03662200015665
• UDI-Public: 03662200015665
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2022
• Report Date (Section F): 08/17/2022

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 28 / 51
• Device Catalogue Number: DS10015128
• Device Lot Number: 2009362A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• 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: DLT TS CER HD 12/14 28MM +8.5; PINNACLE DM LINER 60_51
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Date Report Sent to FDA: 08/17/2022