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	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Insufficient Information (4580)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Notified by dr.(b)(6).On aug.6, 2024 that a patient became infected and the implants had to be removed and were replaced by a fusion nail device.Originally implanted on (b)(6) 2022.Fusion nail procedure completed on (b)(6) 2023.[customer].
Additional Manufacturer Narrative
This is the final supplemental report.The complaint is closed.
Event or Problem Description
Notified by (b)(6) 2024 that a patient became infected and the implants had to be removed and were replaced by a fusion nail device.Originally implanted on (b)(6) 2022.Fusion nail procedure completed on (b)(6) 2023.[customer].

• 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: 20105249
• Report Number: 3004371426-2024-00060
• Device Sequence Number: 8475093
• 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: K152431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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: 15-3817/12
• 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: 08/07/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2020
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 98 KG