MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 28 49; BI MENTUM LINER

Model Number	BI-MENTUM PE Liner 28 / 49
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).
Event or Problem Description
Patient was revised due to dislocation.A constrained liner dislocated and revised to the dual mobility on (b)(6) 2021.She dislocated 2 weeks post op the first time.She was ok until she had a gynecological procedure done a few weeks ago, then her hip hurt and dislocated again on (b)(6) 2022 while trying to get up from sitting in a chair.She was revised to another constrained liner this time.Doi: (b)(6) 2021; 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): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 13938282
• Report Number: 1818910-2022-50018
• Device Sequence Number: 6505357
• Product Code: LPH
• UDI-Device Identifier: 03662200015658
• UDI-Public: 03662200015658
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 03/29/2022
• Report Date (Section F): 03/29/2022

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: 2002752A
• 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: 03/29/2022
• Date Device Manufactured: 10/15/2020
• 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: DLT TS CER HD 12/14 28MM +5.0; PINNACLE DM LINER 56_49
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Date Report Sent to FDA: 03/29/2022