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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 22 41; BI MENTUM LINER
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DEPUY ORTHOPAEDICS INC US BI MENTUM PFRK PE LINER 22 41; BI MENTUM LINER Back to Search Results
Model Number BI-MENTUM PE Liner 22,2 / 41
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 06/13/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem 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).
 
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Brand Name
BI MENTUM PFRK PE LINER 22 41
Common Device Name
BI MENTUM LINER
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12094728
Report Number1818910-2021-50020
Device Sequence Number3975394
Product Code MEH
UDI-Device Identifier03662200015498
UDI-Public03662200015498
Combination Product (Y/N)N
Initial Reporter StateCA
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) 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
Operator of Device Health Professional
Device Model NumberBI-MENTUM PE Liner 22,2 / 41
Device Catalogue NumberDS10014122
Device Lot Number2002693A
Was Device Available for Evaluation? No
Distributor Facility Aware Date06/13/2021
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/30/2021
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 Age52 YR
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