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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SERF BI MENTUM PFRK PE LINER 22 41
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SERF BI MENTUM PFRK PE LINER 22 41 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 Pain (1994)
Date of Event 06/07/2023
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).
 
Event or Problem Description
Patient was revised due to pain.Doi: (b)(6) 2022.Dor: (b)(6) 2023.Affected side: right hip.
 
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Brand Name
BI MENTUM PFRK PE LINER 22 41
Common Device Name
BI MENTUM PFRK PE LINER
Manufacturer (Section D)
SERF
85 avenue des bruyères
décines-charpieu 69150
FR  69150
MDR Report Key17171081
Report Number1818910-2023-150023
Device Sequence Number6593644
Product Code LPH
UDI-Device Identifier03662200015498
UDI-Public03662200015498
Combination Product (Y/N)N
Initial Reporter StateSC
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2022
Device Explanted Year2023
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) 06/21/2023
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 Number2005143A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/21/2023
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured01/12/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ARTICUL/EZE BALL 22.225+4 NK; PINNACLE DM LINER 48_41
Outcome Attributed to Adverse Event Required Intervention;
Patient SexFemale
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