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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 02/20/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).

Event Description

Patient was revised due to pain.Doi: unk, dor: (b)(6) 2022, affected side: right side.

• Brand Name: BI MENTUM PFRK PE LINER 28 49
• Type of Device: BI MENTUM LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 13685073
• MDR Text Key: 286726870
• Report Number: 1818910-2022-50014
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 03662200015658
• UDI-Public: 03662200015658
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2022

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
• Device Operator: Health Professional
• Device Model Number: BI-MENTUM PE Liner 28 / 49
• Device Catalogue Number: DS10014928
• Device Lot Number: 2006238A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2022
• Distributor Facility Aware Date: 02/20/2022
• Date Report to Manufacturer: 03/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2022
• Date Device Manufactured: 12/29/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BI MENTUM PFRK PE LINER 28 49; DLT TS CER HD 12/14 28MM +8.5
• Patient Outcome(s): Required Intervention