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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
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WALDEMAR LINK GMBH & CO. KG ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM Back to Search Results
Model Number 15-8521/10
Medical Device Problem Code Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code Joint Laxity (4526)
Date of Event 04/15/2025
Type of Reportable Event Serious Injury
Event or Problem Description
Reported from a case of a revision to a condylar replacement component, one of the condylar caps was found floating in the joint space upon opening the knee capsule.The case was a revision of the knee for infection where the surgeon was either replacing or removing parts and washing out the knee.The femoral component remained implanted without the cap and only the poly tibial plateau was swapped out during the revision.
 
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Brand Name
ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
Common Device Name
ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
MDR Report Key21942171
Report Number3006721341-2025-00004
Device Sequence Number8691532
Product Code KRO
UDI-Device Identifier04026575381753
UDI-Public(01)04026575381753(17)280331
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
Device Explanted Year2025
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) 05/01/2025
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 Number15-8521/10
Device Catalogue Number15-8521/10
Device Lot Number221205
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/15/2025
Device Age2 YR
Event Location Hospital
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/01/2025
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 Age67 YR
Patient SexMale
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