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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
Model Number 15-8521/12
Device Problems Crack (1135); Naturally Worn (2988)
Patient Problem Failure of Implant (1924)
Event Date 02/06/2015
Event Type  Injury  
Manufacturer Narrative
The reported event is confirmed through investigation. Based on the investigation there is no indication to suggest a material or manufacturing defect. The report is delayed due to inconsistencies with regard to foreign event reporting to fda. After re-evaluation of the complaint we determined that it is reportable. We have addressed the inconsistency in reporting foreign events to fda through capa-(b)(4).
 
Event Description
It was reported that a revision surgery was performed due to instability.
 
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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 Key8296325
MDR Text Key134705743
Report Number3004371426-2019-00010
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K143179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 02/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number15-8521/12
Device Catalogue Number15-8521/12
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2015
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2015
Was Device Evaluated by Manufacturer? Yes
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: 02/01/2019 Patient Sequence Number: 1
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