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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MODULAR JOINT COMPONENT UNIT CONDYLAR REPLACEMENT - MEGASYSTEM-C ROTATING HINGED TOTAL KNEE PROSTHESIS

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WALDEMAR LINK GMBH & CO. KG MODULAR JOINT COMPONENT UNIT CONDYLAR REPLACEMENT - MEGASYSTEM-C ROTATING HINGED TOTAL KNEE PROSTHESIS Back to Search Results
Model Number 15-8521/15
Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994)
Event Date 12/12/2018
Event Type  Injury  
Manufacturer Narrative
The review of the device history record showed no deviations. All product features corresponded with the valid specifications of the waldemar link (b)(4) at the time, when the item was produced.
 
Event Description
During a surgical procedure to implant a patellar component and to address pain and inflammation, a cap of the femoral component was found loose in the joint.
 
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Brand NameMODULAR JOINT COMPONENT UNIT CONDYLAR REPLACEMENT - MEGASYSTEM-C
Type of DeviceROTATING HINGED TOTAL KNEE 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 Key8521592
MDR Text Key142182006
Report Number3004371426-2019-00121
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K143179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2020
Device Model Number15-8521/15
Device Catalogue Number15-8521/15
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2015
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: 04/17/2019 Patient Sequence Number: 1
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