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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG ENDO-MODELL MODULAR; ENDO-M. MOD.ROTATIONKNEE, FEM. COMP.,W. PATELLAR FLANGE,MEDIUM, RIGHT
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WALDEMAR LINK GMBH & CO.KG ENDO-MODELL MODULAR; ENDO-M. MOD.ROTATIONKNEE, FEM. COMP.,W. PATELLAR FLANGE,MEDIUM, RIGHT Back to Search Results
Model Number 15-2812/11
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Failure of Implant (1924)
Event Date 03/19/2024
Event Type  Injury  
Event Description
Femur hat sich vom schaft gelöst.Patient ist anscheinend so schon seit länger zeit rum gelaufen.Schaft war fest im zementmantel.[customer].Translation: femur has detached from the stem.
 
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Brand Name
ENDO-MODELL MODULAR
Type of Device
ENDO-M. MOD.ROTATIONKNEE, FEM. COMP.,W. PATELLAR FLANGE,MEDIUM, RIGHT
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO.KG
barkhausenweg 10
hamburg, hamburg 22339
GM  22339
Manufacturer Contact
andreas brandt
barkhausenweg 10
hamburg, hamburg 22339
GM   22339
MDR Report Key19077844
MDR Text Key339778047
Report Number3004371426-2024-00030
Device Sequence Number1
Product Code KRO
UDI-Device Identifier04026575253159
UDI-Public04026575253159
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K143179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 03/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number15-2812/11
Device Catalogue Number15-2812/11
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/27/2024
Date Manufacturer Received03/20/2024
Was Device Evaluated by Manufacturer? No
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 Age77 YR
Patient SexMale
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