MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL -M; FEMORAL SEGMENTS, CEMENTED, UHMWPE, RIGHT, M, SIZE 4, H=80 MM, WIDTH= 65 MM

Model Number	15-2964/03
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient has a history of fibrosis associated with nickel allergy and pain in his right knee.On (b)(6) 2023 the patient underwent revision surgery during which this porex-coated knee system was implanted with uhmwpe distal femoral and proximal tibial augments.Imaging reveals fractured distal femur cement mantle exposing the augments.Revision surgery is planned pending availability of parts to be provided under compassionate use.[customer].

• Brand Name: ENDO-MODEL -M
• Common Device Name: FEMORAL SEGMENTS, CEMENTED, UHMWPE, RIGHT, M, SIZE 4, H=80 MM, WIDTH= 65 MM
• 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 Key: 19815727
• Report Number: 3004371426-2024-00052
• Device Sequence Number: 8695186
• Product Code: LZO
• UDI-Device Identifier: 04026575205882
• UDI-Public: 04026575205882
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K211768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

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
• Device Model Number: 15-2964/03
• Device Catalogue Number: 15-2964/03
• Device Lot Number: 2146036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2021
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 82 KG