MAUDE Adverse Event Report: SOC ETUDES RECHERCHES FABRICATION BI MENTUM PFRK PE LINER 28 53; BI MENTUM 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 Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The approximate age of device captured in f9 is the length of time the device was implanted in the patient.
Event or Problem Description
The patient was revised due to infection.Doi: (b)(6) 2020 dor: (b)(6) 2020 right hip.

• Brand Name: BI MENTUM PFRK PE LINER 28 53
• Common Device Name: BI MENTUM LINER
• Manufacturer (Section D): SOC ETUDES RECHERCHES FABRICATION; 85 avenue des bruyères; décines-charpieu 69150 ; FR 69150
• MDR Report Key: 10507830
• Report Number: 1818910-2020-50004
• Device Sequence Number: 2992339
• Product Code: LZO
• UDI-Device Identifier: 03662200015672
• UDI-Public: 03662200015672
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2020
• Report Date (Section F): 09/09/2020

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: 1907665A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2020
• 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 PFIT CUP 53; DELTA CER HEAD 12/14 28MM +8.5; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 83
• Date Report Sent to FDA: 09/09/2020