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

Model Number BI-MENTUM PE Liner 28 / 51

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 03/15/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).

Event Description

It was reported that dual mobility components revised for early infection.Doi: (b)(6) 2021: dor: (b)(6) 2021: left hip.

• Brand Name: BI MENTUM PFRK PE LINER 28 51
• Type of Device: BIMENTUM PE LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11596182
• MDR Text Key: 243169317
• Report Number: 1818910-2021-50007
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 03662200015665
• UDI-Public: 03662200015665
• 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: 03/31/2021,03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• 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 / 51
• Device Catalogue Number: DS10015128
• Device Lot Number: 1909287A
• 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: 03/31/2021
• Distributor Facility Aware Date: 03/15/2021
• 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: 65 YR