MAUDE Adverse Event Report: SOC ETUDES RECHERCHES FABRICATION BI MENTUM PFRK PE LINER 28 49; BI MENTUM LINER

Model Number	BI-MENTUM PE Liner 28 / 49
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Patient was revised due to infected total hip.Head and liner was exchanged for irrigation and debridement.Bimentum liner with stryker head was removed and replaced with a new construct due to the presence of infection.Doi: (b)(6) 2022, dor: (b)(6) 2022, affected side: right hip.

• Brand Name: BI MENTUM PFRK PE LINER 28 49
• Common Device Name: BI MENTUM LINER
• Manufacturer (Section D): SOC ETUDES RECHERCHES FABRICATION; 85 avenue des bruyres; dcines-charpieu 69150 ; FR 69150
• MDR Report Key: 14084403
• Report Number: 1818910-2022-50020
• Device Sequence Number: 5251136
• Product Code: KWA
• UDI-Device Identifier: 03662200015658
• UDI-Public: 03662200015658
• 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): 04/12/2022
• Report Date (Section F): 04/12/2022

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 / 49
• Device Catalogue Number: DS10014928
• Device Lot Number: 1907027A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/29/2022
• Date Report to Manufacturer: 03/29/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2022
• Date Device Manufactured: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Date Report Sent to FDA: 04/12/2022