MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG ENDO-MODEL SL KNEE JOINT PROSTHESIS; FEMORAL COMPONENT LEFT, SMALL (2), UHMWPE, COCRMO WITH PATELLAR FLANGE

Model Number	16-2821/22
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The prosthesis was implanted on (b)(6) 2024 while the packaging stated the expiry date as 31/01/2024.[customer].
Additional Manufacturer Narrative
Off label use, as the expiry date was exceeded by 12 days before use.
Event or Problem Description
The prosthesis was implanted on (b)(6) 2024 while the packaging stated the expiry date as (b)(6) 2024.Customer.
Additional Manufacturer Narrative
Off label use, as the expiry date was exceeded by 12 days before use.This is the final supplemental report, the complaint is closed.

• Brand Name: ENDO-MODEL SL KNEE JOINT PROSTHESIS
• Common Device Name: FEMORAL COMPONENT LEFT, SMALL (2), UHMWPE, COCRMO WITH PATELLAR FLANGE
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO.KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 19031240
• Report Number: 3004371426-2024-00033
• Device Sequence Number: 8120627
• Product Code: KRO
• UDI-Device Identifier: 04026575392247
• UDI-Public: 04026575392247
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K151008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 16-2821/22
• Device Catalogue Number: 16-2821/22
• 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: 03/20/2024
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2019
• 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
• Patient Sex: Female