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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOC ETUDES RECHERCHES FABRICATION BI MENTUM PFRK PE LINER 28 61 BI MENTUM LINER

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SOC ETUDES RECHERCHES FABRICATION BI MENTUM PFRK PE LINER 28 61 BI MENTUM LINER Back to Search Results
Model Number BI-MENTUM PE Liner 28 / 61
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/21/2020
Event Type  Injury  
Manufacturer Narrative

(b)(4). The approximate age of device captured in is the length of time the device was implanted in the patient.

 
Event Description

It was reported that patient had very high hip center on primary hip performed in (b)(6) of 2019 and at that time patient was left short. Today, a longer stem was placed to get the patient back closer to equal leg lengths. Doi: (b)(6) 2019. Dor: (b)(6) 2020. Right hip.

 
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Brand NameBI MENTUM PFRK PE LINER 28 61
Type of DeviceBI MENTUM LINER
Manufacturer (Section D)
SOC ETUDES RECHERCHES FABRICATION
85 avenue des bruyères
décines-charpieu 69150
FR  69150
MDR Report Key10164295
Report Number1818910-2020-50003
Device Sequence Number1
Product CodeLZO
Report Source Distributor
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 06/17/2020,05/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberBI-MENTUM PE Liner 28 / 61
Device Catalogue NumberDS10016128
Device LOT Number1904328A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/17/2020
Distributor Facility Aware Date05/21/2020
Device Age5 mo
Event Location Hospital
Date Report TO Manufacturer06/17/2020
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: 06/17/2020 Patient Sequence Number: 1
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