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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL KNEE PROSTHESIS SYSTEM; DISTAL FEMORAL REPLACEMENT COMPONENTS,MODULAR
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WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL KNEE PROSTHESIS SYSTEM; DISTAL FEMORAL REPLACEMENT COMPONENTS,MODULAR Back to Search Results
Model Number 16-2853/21
Health Effect - Clinical Code Failure of Implant (1924)
Type of Reportable Event Serious Injury
Event or Problem Description
On (b)(6) 2022, lb become aware of a junction failure of the proximal femoral component and distal femoral stem segment, which per sales rep happened in early december 2021.The revision surgery performed on (b)(6) 2021 was successful.
 
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Brand Name
ENDO-MODEL SL KNEE PROSTHESIS SYSTEM
Common Device Name
DISTAL FEMORAL REPLACEMENT COMPONENTS,MODULAR
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
MDR Report Key14346828
Report Number3006721341-2022-00004
Device Sequence Number19872508
Product Code KRO
UDI-Device Identifier04026575383306
UDI-Public04026575383306
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/03/2022
Report Date (Section F) 05/04/2022
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? Yes
Operator of Device Health Professional
Device Expiration Date06/30/2022
Device Model Number16-2853/21
Device Catalogue Number16-2853/21
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/03/2022
Date Report to Manufacturer05/04/2022
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/10/2022
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; Hospitalization;
Patient Age72 YR
Patient SexMale
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