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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MEGA-C ENDO SL; CONNECTION COMPONENT ROTATING HINGE - LARGE
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WALDEMAR LINK GMBH & CO. KG MEGA-C ENDO SL; CONNECTION COMPONENT ROTATING HINGE - LARGE Back to Search Results
Model Number 16-2840/07
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Medical device site infection (4845)
Type of Reportable Event Serious Injury
Event or Problem Description
Notified by (b)(6) of a revision to a special access order with dr.(b)(6) because of an infected distal femur requiring a washout and exchange of components.The surgeon stated that in his opinion the implant did not cause the infection.The surgeon believes that the infection is due to the patient being immunocompromised due to chemotherapy.
 
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Brand Name
MEGA-C ENDO SL
Common Device Name
CONNECTION COMPONENT ROTATING HINGE - LARGE
Manufacturer (Section D)
WALDEMAR LINK GMBH & CO. KG
barkhausenweg 10
hamburg, 22339
GM  22339
MDR Report Key24336335
Report Number3006721341-2026-00002
Device Sequence Number5017992
Product Code KRO
UDI-Device Identifier04026575359257
UDI-Public04026575359257
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2025
Device Explanted Year2026
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) 02/13/2026
Report Date (Section F) 01/21/2026
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
Device Model Number16-2840/07
Device Catalogue Number16-2840/07
Device Lot Number240823
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/16/2026
Event Location Hospital
Date Report to Manufacturer01/21/2026
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date02/13/2026
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 SexUnknown
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