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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL FEMORAL COMPONENT, INTRACONDYLAR MODULAR CEMENTED ROTATIONAL KNEE

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WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL FEMORAL COMPONENT, INTRACONDYLAR MODULAR CEMENTED ROTATIONAL KNEE Back to Search Results
Model Number 16-2825/21
Device Problems Detachment of Device or Device Component (2907); Osseointegration Problem (3003)
Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)
Event Date 05/30/2021
Event Type  Injury  
Manufacturer Narrative
The review of the device history record showed no deviations. The product complies with the specifications valid at the time of manufacture.
 
Event Description
Dislocation between femoral component and stem [customer].
 
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Brand NameENDO-MODEL SL
Type of DeviceFEMORAL COMPONENT, INTRACONDYLAR MODULAR CEMENTED ROTATIONAL KNEE
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM 22339
Manufacturer Contact
annerike tizia hucklenbroch
barkhausenweg 10
hamburg, 22339
GM   22339
MDR Report Key12030803
MDR Text Key257138628
Report Number3004371426-2021-00017
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
Type of Report Initial,Followup
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number16-2825/21
Device Catalogue Number16-2825/21
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received06/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2020
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: 06/21/2021 Patient Sequence Number: 1
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