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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ROTATIONAL JOINT COMPONENT UNIT CEMENTABLE ENDO-MODEL MODULAR KNEE SYSTEM ROTATING HINGED TOTAL KNEE PROSTHESIS

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WALDEMAR LINK GMBH & CO. KG ROTATIONAL JOINT COMPONENT UNIT CEMENTABLE ENDO-MODEL MODULAR KNEE SYSTEM ROTATING HINGED TOTAL KNEE PROSTHESIS Back to Search Results
Model Number 15-2817/11
Device Problems Break (1069); Naturally Worn (2988)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 08/31/2017
Event Type  Injury  
Manufacturer Narrative
The review of the device history record showed no deviations. All product features corresponded with the valid specifications at the time, when the item was produced. The investigation is in progress.
 
Event Description
It was reported that a revision surgery was performed due to damage of the bushing.
 
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Brand NameROTATIONAL JOINT COMPONENT UNIT CEMENTABLE ENDO-MODEL MODULAR KNEE SYSTEM
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 Key8292120
MDR Text Key134564665
Report Number3004371426-2019-00109
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 foreign,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2018
Device Model Number15-2817/11
Device Catalogue Number15-2817/11
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2009
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: 01/31/2019 Patient Sequence Number: 1
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