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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL STANDARD KNEE PROSTHESIS SYSTEM
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WALDEMAR LINK GMBH & CO. KG ENDO-MODEL STANDARD KNEE PROSTHESIS SYSTEM Back to Search Results
Model Number 15-0027/14
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Ambulation or Postural Difficulties (2544)
Type of Reportable Event Serious Injury
Event or Problem Description
Patient presented with difficulty walking, combined with clicking and locking in the right knee subsequent to a dec 2022 tka (revision).X-rays shows some offset of femur with respect to the tibial plateau.Both the femoral and tibial components appear securely fixed on x-ray.Revision surgery is scheduled for 01/23/2024.
 
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Brand Name
ENDO-MODEL STANDARD KNEE PROSTHESIS SYSTEM
Common Device Name
ENDO-MODEL STANDARD KNEE PROSTHESIS SYSTEM
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
MDR Report Key18477841
Report Number3006721341-2024-00002
Device Sequence Number15184455
Product Code KRO
UDI-Device Identifier04026575432110
UDI-Public(01)04026575432110(17)270731(10)
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2023
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 01/09/2024
Report Date (Section F) 01/09/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number15-0027/14
Device Catalogue Number15-0027/14
Device Lot Number2231118
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/12/2023
Device Age1 YR
Date Report to Manufacturer01/09/2024
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/09/2024
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age71 YR
Patient SexMale
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