MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL - M; KNEE PROSTHESIS, KNEE-JOINT PROSTHESIS LEFT, SMALL, PRODUCT

Model Number	15-3816/12
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Notified by representative (b)(6) that dr.(b)(6) will perform a revision for a femur that it loose.Revision is planned for (b)(6) 2024.[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
Notified by representative (b)(6) that dr.(b)(6) will perform a revision for a femur that it loose.Revision is planned for (b)(6) 2024.[(b)(6)].

• Brand Name: ENDO-MODEL - M
• Common Device Name: KNEE PROSTHESIS, KNEE-JOINT PROSTHESIS LEFT, SMALL, PRODUCT
• 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: 20986803
• Report Number: 3004371426-2024-00080
• Device Sequence Number: 7824631
• Product Code: KRO
• UDI-Device Identifier: 04026575034758
• UDI-Public: 04026575034758
• 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
• 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): 11/27/2024

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 Model Number: 15-3816/12
• Device Catalogue Number: 15-3816/12
• 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: 11/27/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2023
• 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: 61 YR
• Patient Sex: Female