MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM

Model Number	15-3816/12
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient has severe nickel allergy.System was implanted during revision tka on (b)(6) 2020 and metal augments were revised to uhmwpe augments on (b)(6) 2021.Patient has knee pain which appears localized to the femur and augments and possibly to patella femoral joint.Surgeon plans revision pending request under compassionate use for tinbn-coated metal augments and taper fixation screws.Surgery has not yet occurred.A letter received from dr.(b)(6) on (b)(6) 2024, stating that in his opinion, the poly augments may have contributed to loosening.

• 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 Key: 19386580
• Report Number: 3006721341-2024-00014
• Device Sequence Number: 19842513
• Product Code: KRO
• UDI-Device Identifier: 04026575034758
• UDI-Public: 04026575034758
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/23/2024
• Report Date (Section F): 05/08/2024

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 Expiration Date: 01/31/2025
• Device Model Number: 15-3816/12
• Device Catalogue Number: 15-3816/12
• Device Lot Number: 161205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/07/2024
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 82 KG