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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, MEDIUM ROTATING HINGED TOTAL KNEE PROSTHESIS

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WALDEMAR LINK GMBH & CO. KG CONNECTION COMPONENT, ROTATIONAL VERSION, MEDIUM ROTATING HINGED TOTAL KNEE PROSTHESIS Back to Search Results
Model Number 16-2840/05
Device Problem Connection Problem (2900)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/04/2020
Event Type  Injury  
Event Description
On 2020-12-08, linkbio became aware of a failed connection component that was originally implanted on (b)(6) 2016 (part # 16-2840/05, sn # (b)(4)). A new connection component (part # 16-2840/05, sn # (b)(4)) was implanted during the revision surgery on (b)(6) 2020.
 
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Brand NameCONNECTION COMPONENT, ROTATIONAL VERSION, MEDIUM
Type of DeviceROTATING HINGED TOTAL KNEE PROSTHESIS
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM 22339
MDR Report Key11008828
MDR Text Key221497827
Report Number3006721341-2020-00003
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 12/14/2020,12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2021
Device Model Number16-2840/05
Device Catalogue Number16-2840/05
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/14/2020
Distributor Facility Aware Date12/08/2020
Device Age4 YR
Event Location No Information
Date Report to Manufacturer12/11/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/15/2020 Patient Sequence Number: 1
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