MAUDE Adverse Event Report: SOC ETUDES RECHERCHES FABRICATION BI MENTUM PFRK PFIT CUP 53; BI MENTUM CUP

Model Number	BI-MENTUM PressFit Cup 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
Product complaint # (b)(4).
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 PFIT CUP 53
• Common Device Name: BI MENTUM CUP
• Manufacturer (Section D): SOC ETUDES RECHERCHES FABRICATION; 85 avenue des bruyères; décines-charpieu 69150 ; FR 69150
• MDR Report Key: 10507773
• Report Number: 1818910-2020-50005
• Device Sequence Number: 16892122
• Product Code: LZO
• UDI-Device Identifier: 03662200015009
• UDI-Public: 03662200015009
• 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

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 PressFit Cup 53
• Device Catalogue Number: DS45320153
• Device Lot Number: 1905203A
• Was Device Available for Evaluation?: No
• 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 PE LINER 28 53; DELTA CER HEAD 12/14 28 MM +8.5; UNKNOWN HIP FEMORAL STEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 83