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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL® MODULAR KNEE SYSTEM
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WALDEMAR LINK GMBH & CO. KG ENDO-MODEL® MODULAR KNEE SYSTEM Back to Search Results
Model Number 15-2818/11
Device Problems Break (1069); Fracture (1260)
Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)
Event Date 12/17/2018
Event Type  Injury  
Event Description
Change roknep m after shaft break. Femur was loosened in the cement coat and could be pulled out easily. Tibial shaft was firm and had to be knocked out. The patient was again provided with a new roknep m.
 
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Brand NameENDO-MODEL® MODULAR KNEE SYSTEM
Type of DeviceENDO-MODEL® MODULAR KNEE SYSTEM
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM 22339
Manufacturer (Section G)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM 22339
Manufacturer Contact
omid rahmatian
barkhausenweg 10
hamburg, 22339
GM   22339
MDR Report Key8252786
MDR Text Key133219621
Report Number3004371426-2019-00003
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 company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2016
Device Model Number15-2818/11
Device Catalogue Number15-2818/11
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2011
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: 01/16/2019 Patient Sequence Number: 1
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