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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG DISTAL FEMORALREPLACEMENT COMP. F.LINK® KNEE-SYSTEM

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WALDEMAR LINK GMBH & CO. KG DISTAL FEMORALREPLACEMENT COMP. F.LINK® KNEE-SYSTEM Back to Search Results
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Event Description
Based on the x-rays provided, it appears that the modular stem has dissociated from the femoral components.
 
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Brand NameDISTAL FEMORALREPLACEMENT COMP. F.LINK® KNEE-SYSTEM
Type of DeviceDISTAL FEMORALREPLACEMENT COMP. F.LINK® KNEE-SYSTEM
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM 22339
MDR Report Key8446128
MDR Text Key139672412
Report Number3006721341-2019-00008
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 03/04/2019,02/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/25/2019
Event Location No Information
Date Report to Manufacturer03/04/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/22/2019 Patient Sequence Number: 1
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