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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 49 BI MENTUM LINER

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SOC ETUDES RECHERCHES FABRICATION BI MENTUM PFRK PE LINER 28 49 BI MENTUM LINER Back to Search Results
Model Number BI-MENTUM PE Liner 28 / 49
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Unspecified Infection (1930)
Event Date 03/26/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Patient was revised due to infected total hip. Head and liner was exchanged for irrigation and debridement. Bimentum liner with stryker head was removed and replaced with a new construct due to the presence of infection. Doi: (b)(6) 2022, dor: (b)(6) 2022, affected side: right hip.
 
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Brand NameBI MENTUM PFRK PE LINER 28 49
Type of DeviceBI MENTUM LINER
Manufacturer (Section D)
SOC ETUDES RECHERCHES FABRICATION
85 avenue des bruyres
dcines-charpieu 69150
FR 69150
MDR Report Key14084403
MDR Text Key289087842
Report Number1818910-2022-50020
Device Sequence Number1
Product Code KWA
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 04/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberBI-MENTUM PE Liner 28 / 49
Device Catalogue NumberDS10014928
Device Lot Number1907027A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/12/2022
Distributor Facility Aware Date03/29/2022
Date Report to Manufacturer03/29/2022
Date Manufacturer Received03/26/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/18/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/12/2022 Patient Sequence Number: 1
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