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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG CONNECTION COMPONENT ROTATIONAL VERSION V02 - ROTATIONAL KNEE SL; ROTATING HINGED TOTAL KNEE PROSTHESIS
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WALDEMAR LINK GMBH & CO. KG CONNECTION COMPONENT ROTATIONAL VERSION V02 - ROTATIONAL KNEE SL; ROTATING HINGED TOTAL KNEE PROSTHESIS Back to Search Results
Model Number 16-2840/02
Device Problems Defective Component (2292); Connection Problem (2900); Detachment of Device or Device Component (2907)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Date 10/30/2018
Event Type  Injury  
Manufacturer Narrative
The investigation is in progress.
 
Event Description
It was reported that a defective connection component was replaced with a new connection component during a revision surgery.
 
Manufacturer Narrative
The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time, when the item was produced.
 
Event Description
It was reported that revision surgery was conducted to explant a dislocated connection component.
 
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Brand Name
CONNECTION COMPONENT ROTATIONAL VERSION V02 - ROTATIONAL KNEE SL
Type of Device
ROTATING HINGED TOTAL KNEE PROSTHESIS
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
MDR Report Key8110145
MDR Text Key128581157
Report Number3004371426-2018-00017
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
PMA/PMN Number
K151008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 10/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/31/2023
Device Model Number16-2840/02
Device Catalogue Number16-2840/02
Was Device Available for Evaluation? No
Date Manufacturer Received10/31/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age76 YR
Patient Weight114
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