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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 ROTATING HINGED TOTAL KNEE PROSTHESIS

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WALDEMAR LINK GMBH & CO. KG CONNECTION COMPONENT ROTATIONAL VERSION ROTATING HINGED TOTAL KNEE PROSTHESIS Back to Search Results
Catalog Number 16-2840/02
Device Problems Degraded (1153); Mechanical Problem (1384); Connection Problem (2900); Device Dislodged or Dislocated (2923)
Patient Problems Failure of Implant (1924); Metal Related Pathology (4530)
Event Date 06/26/2021
Event Type  Injury  
Event Description
It was reported that a revision surgery took place to address a dislocation of a failed connection component. This report concerns the same patient as report 3004371426-2017-00002 and 3004371426-2020-00017.
 
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Brand NameCONNECTION COMPONENT ROTATIONAL VERSION
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 Key12115193
MDR Text Key259989540
Report Number3004371426-2021-00018
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number16-2840/02
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 Received06/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2019
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: 07/05/2021 Patient Sequence Number: 1
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