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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL FEMORAL COMPONENT, INTRACONDYLAR UNCOATED KNEE FEMUR PROSTHESIS

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WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL FEMORAL COMPONENT, INTRACONDYLAR UNCOATED KNEE FEMUR PROSTHESIS Back to Search Results
Catalog Number 16-2825/22
Device Problems Material Fragmentation (1261); Failure to Osseointegrate (1863); Detachment of Device or Device Component (2907)
Patient Problems Failure of Implant (1924); Insufficient Information (4580)
Event Date 10/28/2021
Event Type  Injury  
Event Description
It was reported that a revision surgery is scheduled to address a disconnection of the femoral component.
 
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Brand NameENDO-MODEL SL FEMORAL COMPONENT, INTRACONDYLAR
Type of DeviceUNCOATED KNEE FEMUR PROSTHESIS
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM 22339
Manufacturer Contact
rebekka winterhoff
barkhausenweg 10
hamburg, 22339
GM   22339
MDR Report Key12785173
MDR Text Key284885258
Report Number3004371426-2021-00028
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K151008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number16-2825/22
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received10/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/10/2021 Patient Sequence Number: 1
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