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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG FEMORAL COMPONENT INTRACONDYLAR MODULAR UNCOATED KNEE FEMUR PROSTHESIS

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WALDEMAR LINK GMBH & CO. KG FEMORAL COMPONENT INTRACONDYLAR MODULAR UNCOATED KNEE FEMUR PROSTHESIS Back to Search Results
Catalog Number 16-2823/21
Device Problems Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)
Event Date 11/30/2020
Event Type  Injury  
Event Description
It was reported that a revision surgery was performed due to loosening between femoral component and stem.
 
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Brand NameFEMORAL COMPONENT INTRACONDYLAR MODULAR
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 Key11019038
MDR Text Key221745636
Report Number3004371426-2020-00020
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 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2021
Device Catalogue Number16-2823/21
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2016
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: 12/16/2020 Patient Sequence Number: 1
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