MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 28 51; BIMENTUM ACETABULAR LINER

Model Number	BI-MENTUM PE Liner 28 / 51
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised due to hip dislocation.Doi : unknown dor : (b)(6) 2021 right hip.

• Brand Name: BI MENTUM PFRK PE LINER 28 51
• Common Device Name: BIMENTUM ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12917094
• Report Number: 1818910-2021-50045
• Device Sequence Number: 20082226
• Product Code: LPH
• UDI-Device Identifier: 03662200015665
• UDI-Public: 03662200015665
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 11/16/2021
• Report Date (Section F): 12/02/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: BI-MENTUM PE Liner 28 / 51
• Device Catalogue Number: DS10015128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2021
• 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 51; PINNACLE DM LINER TRIAL 60_51
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 28 KG
• Date Report Sent to FDA: 12/02/2021