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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
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 03/15/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).
 
Event or Problem 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 Name
BI MENTUM PFRK PE LINER 28 51
Common Device Name
BIMENTUM PE LINER
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11596182
Report Number1818910-2021-50007
Device Sequence Number3449488
Product Code KWY
UDI-Device Identifier03662200015665
UDI-Public03662200015665
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
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) 03/15/2021
Report Date (Section F) 03/31/2021
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
Operator of Device Health Professional
Device Model NumberBI-MENTUM PE Liner 28 / 51
Device Catalogue NumberDS10015128
Device Lot Number1909287A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date03/15/2021
Type of Report(Section G)Initial
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/31/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age65 YR
Date Report Sent to FDA03/31/2021
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