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U.S. Department of Health and Human Services

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

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DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 28 51 BIMENTUM PE LINER Back to Search Results
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.
 
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Brand NameBI MENTUM PFRK PE LINER 28 51
Type of DeviceBIMENTUM PE LINER
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11596182
MDR Text Key243169317
Report Number1818910-2021-50007
Device Sequence Number1
Product Code KWY
UDI-Device Identifier03662200015665
UDI-Public03662200015665
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received03/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberBI-MENTUM PE Liner 28 / 51
Device Catalogue NumberDS10015128
Device Lot Number1909287A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/31/2021
Distributor Facility Aware Date03/15/2021
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/31/2021 Patient Sequence Number: 1
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