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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL CONNECTION COMPONENT ROTATIONAL VERSION; ROTATING HINGED TOTAL KNEE PROSTHESIS
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WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL CONNECTION COMPONENT ROTATIONAL VERSION; ROTATING HINGED TOTAL KNEE PROSTHESIS Back to Search Results
Catalog Number 16-2840/02
Device Problems Degraded (1153); Fracture (1260); Unstable (1667)
Patient Problem Failure of Implant (1924)
Event Date 02/18/2021
Event Type  Injury  
Event Description
A breakage of polyethylene components was reported.
 
Event Description
A functional limitation and suspicion of rupture of the components was reported.
 
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Brand Name
ENDO-MODEL SL CONNECTION COMPONENT ROTATIONAL VERSION
Type of Device
ROTATING 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 Key11568144
MDR Text Key242211242
Report Number3004371426-2021-00007
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K151008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/28/2018
Device Catalogue Number16-2840/02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received03/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age40 YR
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