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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG REPLACEMENT SET FOR ENDO-MODEL ROTATION KNEE JOINT PROSTHESIS ROTATING HINGED TOTAL KNEE PROSTHESIS

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WALDEMAR LINK GMBH & CO. KG REPLACEMENT SET FOR ENDO-MODEL ROTATION KNEE JOINT PROSTHESIS ROTATING HINGED TOTAL KNEE PROSTHESIS Back to Search Results
Model Number 99-0027/12
Device Problems Unstable (1667); Naturally Worn (2988)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 05/09/2019
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. Further information and the explanted components were requested.
 
Event Description
It was reported that a revision surgery was performed due to knee instability.
 
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Brand NameREPLACEMENT SET FOR ENDO-MODEL ROTATION KNEE JOINT PROSTHESIS
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 Key8691143
MDR Text Key147727705
Report Number3004371426-2019-00124
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K821476
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 05/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2019
Device Model Number99-0027/12
Device Catalogue Number99-0027/12
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2014
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: 06/12/2019 Patient Sequence Number: 1
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