MAUDE Adverse Event Report: SERF BI MENTUM PFRK PE LINER 22 45; BI MENTUM LINER

Model Number	BI-MENTUM PE Liner 22,2 / 45
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was revised with hip dislocation and was out for a week so the leg was vary contracted.Surgeon first started by removing dual mobility and putting in a constrained liner tried to reduce a 32 +5 head but with the leg being contracted, it was unable to get the hip reduced , then tried a 32 +1 head and after many attempts.Surgeon finally reduced the hip but cracked the top of the constrained liner, after 30 minutes of removing the constrained liner surgeon went with a 36 +4 10* liner and 36 +8.5 head.Doi: (b)(6) 2022.Dor: unknown.Affected side: left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).

• Brand Name: BI MENTUM PFRK PE LINER 22 45
• Common Device Name: BI MENTUM LINER
• Manufacturer (Section D): SERF; 85 avenue des bruyères; décines-charpieu 69150 ; FR 69150
• MDR Report Key: 16815097
• Report Number: 1818910-2023-150017
• Device Sequence Number: 12195950
• Product Code: LPH
• UDI-Device Identifier: 03662200015511
• UDI-Public: 03662200015511
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 04/26/2023
• Report Date (Section F): 04/26/2023

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 Model Number: BI-MENTUM PE Liner 22,2 / 45
• Device Catalogue Number: DS10014522
• Device Lot Number: 2005145A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2020
• 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: ARTICUL/EZE BALL 22.225+7 NK; BI MENTUM PFRK PE LINER 22 45; DLT TS CER HD 12/14 32MM +1; DLT TS CER HD 12/14 32MM +5; PINN LNR CON +4 NEUT 32IDX52OD; PINN LNR CON +4 NEUT 32IDX52OD; PINNACLE DM LINER 52_45
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Date Report Sent to FDA: 04/26/2023