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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 16-2840/05
Device Problems Degraded (1153); Unstable (1667); Naturally Worn (2988)
Patient Problem Failure of Implant (1924)
Event Date 08/25/2021
Event Type  Injury  
Event Description
It was reported that a revision surgery was performed due to instability and wear.
 
Event Description
It was reported that a revision surgery was performed due to instability and wear.
 
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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 Key12511666
MDR Text Key272678168
Report Number3004371426-2021-00027
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGM
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 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/30/2017
Device Catalogue Number16-2840/05
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received08/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2012
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;
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