MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 22 41; BI MENTUM LINER

Model Number BI-MENTUM PE Liner 22,2 / 41

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/13/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient presented an infection for the second time.The liner and head was removed and replaced.The patient was i&d and cultures were done.No other information is available.Doi: (b)(6) 2021 - dor: (b)(6) 2021 (right hip).

• Brand Name: BI MENTUM PFRK PE LINER 22 41
• Type of Device: BI MENTUM LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12094728
• MDR Text Key: 259361721
• Report Number: 1818910-2021-50020
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 03662200015498
• UDI-Public: 03662200015498
• 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: 06/13/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: BI-MENTUM PE Liner 22,2 / 41
• Device Catalogue Number: DS10014122
• Device Lot Number: 2002693A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/13/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR