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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG FEMORAL COMPONENT CONDYLAR REPLACEMENT MEGASYSTEM-C UNCOATED KNEE FEMUR PROSTHESIS

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WALDEMAR LINK GMBH & CO. KG FEMORAL COMPONENT CONDYLAR REPLACEMENT MEGASYSTEM-C UNCOATED KNEE FEMUR PROSTHESIS Back to Search Results
Catalog Number 15-8521/06
Device Problems Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Patient Problems Ossification (1428); Failure of Implant (1924); Synovitis (2094)
Event Date 04/20/2021
Event Type  Injury  
Event Description
We were initially informed that during a washout for an infection on (b)(6) 2021, the surgeon made an observation that the condyle cap of the femoral component had come loose. Upon review of the surgery report it was revealed that a loosening of the femoral component had occurred.
 
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Brand NameFEMORAL COMPONENT CONDYLAR REPLACEMENT MEGASYSTEM-C
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 Key12201481
MDR Text Key262619870
Report Number3004371426-2021-00021
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number15-8521/06
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2018
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: 07/21/2021 Patient Sequence Number: 1
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