MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL KNEE SYSTEM / LINK ENDO-MODEL EVO KNEE; ENDO-MODEL -M, MODULAR STEMS, CEMENTED, COCRMO, CONICAL, L= 120MM, Ø=16 MM

Model Number	15-2950/04
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Metal Related Pathology (4530)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Side: left.Diagnosis: femoral shaft fracture with possible metallosis? revision of the cemented 120mm femoral shaft, the size m femoral component, the size 3 femoral segment and the tibial plateau.The tibia was firmly anchored.The femoral shaft is broken or fragmented at the distal end or at the attachment to the femoral cone in several places.Removal of the shaft was difficult because no loosening was detectable.The hole for screw fixation was widened with a drill to allow a removal hook to be attached and the stem to be removed with a hammer.After removal of the stem, irrigation and insertion of low-viscosity cement, the following was implanted: femoral component 15-2817/12 replacement plateau 150027/15 modular stem 15-2950/06 femoral segment 15-2978/02 a very satisfactory result was achieved.[customer].
Additional Manufacturer Narrative
The review of the history record showed no deviations.The product complies with the specifications valid at the time of manufacture.This is the final supplemental report.The complaint is closed.
Event or Problem Description
Side: left.Diagnosis: femoral shaft fracture with possible metallosis? revision of the cemented 120mm femoral shaft, the size m femoral component, the size 3 femoral segment and the tibial plateau.The tibia was firmly anchored.The femoral shaft is broken or fragmented at the distal end or at the attachment to the femoral cone in several places.Removal of the shaft was difficult because no loosening was detectable.The hole for screw fixation was widened with a drill to allow a removal hook to be attached and the stem to be removed with a hammer.After removal of the stem, irrigation and insertion of low-viscosity cement, the following was implanted: femoral component 15-2817/12.Replacement plateau 150027/15.Modular stem 15-2950/06.Femoral segment 15-2978/02.A very satisfactory result was achieved.[(b)(6)].

• Brand Name: ENDO-MODEL KNEE SYSTEM / LINK ENDO-MODEL EVO KNEE
• Common Device Name: ENDO-MODEL -M, MODULAR STEMS, CEMENTED, COCRMO, CONICAL, L= 120MM, Ø=16 MM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 21111586
• Report Number: 3004371426-2025-00001
• Device Sequence Number: 8719451
• Product Code: KRO
• UDI-Device Identifier: 04026575319015
• UDI-Public: 04026575319015
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K143179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2016
• Device Model Number: 15-2950/04
• Device Catalogue Number: 15-2950/04
• Device Lot Number: 1128111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR
• Patient Sex: Male