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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL® ROTATION KNEE JOINT PROSTHESIS WITH POREX® SURFACE CEMENTED ROTATING HINGED TOTAL KNEE PROSTHESIS

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WALDEMAR LINK GMBH & CO. KG ENDO-MODEL® ROTATION KNEE JOINT PROSTHESIS WITH POREX® SURFACE CEMENTED ROTATING HINGED TOTAL KNEE PROSTHESIS Back to Search Results
Model Number 15-9020/12
Device Problems Crack (1135); Device Dislodged or Dislocated (2923); Naturally Worn (2988); Appropriate Term/Code Not Available (3191)
Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692); No Known Impact Or Consequence To Patient (2692)
Event Date 01/29/2019
Event Type  Injury  
Event Description
It was reported that a revision surgery was performed due to luxation of the femoral component.
 
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Brand NameENDO-MODEL® ROTATION KNEE JOINT PROSTHESIS WITH POREX® SURFACE CEMENTED
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 Key8397972
MDR Text Key138073675
Report Number3004371426-2019-00114
Device Sequence Number0
Product Code KRO
Reporter Country CodeGM
PMA/PMN Number
K152431
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/07/2019
2 Devices were Involved in the Event: 1   2  
2 Patients were Involved in the Event: 1   2  
Date FDA Received03/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number15-9020/12
Device Catalogue Number15-9020/12
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/01/2018
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: 03/07/2019 Patient Sequence Number: 0
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