MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL -M; ROTATIONAL KNEE PROSTHESIS, KNEE-JOINT PROSTHESIS LEFT, MEDIUM, COCRMO/TINBN

Model Number	15-3817/12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
This device was implanted (b)(6) 2021.Patient is a 79 year old man with nickel allergy and history or worsening pain in his left knee.Patient is scheduled for revision due to apparent infection.[customer].
Additional Manufacturer Narrative
This is the final supplemental report.The complaint is closed.
Event or Problem Description
This device was implanted (b)(6) 2021.Patient is a 79-year-old man with nickel allergy and history or worsening pain in his left knee.Patient is scheduled for revision due to apparent infection.

• Brand Name: ENDO-MODEL -M
• Common Device Name: ROTATIONAL KNEE PROSTHESIS, KNEE-JOINT PROSTHESIS LEFT, MEDIUM, COCRMO/TINBN
• 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: 19815726
• Report Number: 3004371426-2024-00053
• Device Sequence Number: 12935426
• Product Code: KRO
• UDI-Device Identifier: 04026575164059
• UDI-Public: 04026575164059
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K212742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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 Expiration Date: 10/31/2025
• Device Model Number: 15-3817/12
• Device Catalogue Number: 15-3817/12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2020
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 86 KG