MAUDE Adverse Event Report: SERF BI MENTUM PFRK PE LINER 28 53; JRN : DISTRIBUTED PRODUCTS

Catalog Number	DS10015328
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was revised due to infection.Doi: unknown, dor: (b)(6) 2023, affected side: unknown hip.

• Brand Name: BI MENTUM PFRK PE LINER 28 53
• Common Device Name: JRN : DISTRIBUTED PRODUCTS
• Manufacturer (Section D): SERF; 85 avenue des bruyères; décines-charpieu 69150 ; FR 69150
• MDR Report Key: 17491583
• Report Number: 1818910-2023-150040
• Device Sequence Number: 15409390
• Product Code: LPH
• UDI-Device Identifier: 03662200015672
• UDI-Public: 03662200015672
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/09/2023
• Report Date (Section F): 08/09/2023

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 Catalogue Number: DS10015328
• Device Lot Number: 2009434A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/26/2023
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2023
• 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: DELTA CER HEAD 12/14 28MM +1.5; PINNACLE DM LINER 62_53
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/09/2023