MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 22 43

Model Number	BI-MENTUM PE Liner 22,2 / 43
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision completed due to joint instability.The mdm construct was revised with pinnacle constrained.Doi: unknown.Dor: (b)(6) 2022, affected side: left hip.
Additional Manufacturer Narrative
Product complaint # (b)(4).

• Brand Name: BI MENTUM PFRK PE LINER 22 43
• Common Device Name: BI MENTUM PFRK PE LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 13388731
• Report Number: 1818910-2022-50010
• Device Sequence Number: 4935224
• Product Code: LPH
• UDI-Device Identifier: 03662200015504
• UDI-Public: 03662200015504
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/27/2022
• Report Date (Section F): 01/28/2022

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 22,2 / 43
• Device Catalogue Number: DS10014322
• Device Lot Number: 2002699A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2022
• 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: 81 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/28/2022