MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL-M; SLEDKNEE PROSTHESIS,LARGE

Model Number	15-2020/60
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	04/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The findings from the arthroscopy were: hyperplastic yellowish synovial membrane with red and brown speckling, with biopsies taken from these spots and the synovial fluid.Patellar chondromalacia grade ii-iii affecting approximately 30% of the patella.Normal trochlea, lateral compartment with a zone of approximately 5 x 3 mm of chondromalacia grade ii-ii in the lateral femoral condyle, and intact cruciate ligaments.[customer].
Additional Manufacturer Narrative
The review of the device 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
Hyperplastic yellowish synovial membrane with red and brown speckling, with biopsies taken from these spots and the synovial fluid.Patellar chondromalacia grade ii-iii affecting approximately 30% of the patella.Normal trochlea, lateral compartment with a zone.Of approximately 5 x 3 mm of chondromalacia grade ii-ii in the lateral femoral condyle, and intact cruciate ligaments.[customer].

• Brand Name: ENDO-MODEL-M
• Common Device Name: SLEDKNEE PROSTHESIS,LARGE
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 20074618
• Report Number: 3004371426-2024-00059
• Device Sequence Number: 6395339
• Product Code: HSX
• UDI-Device Identifier: 04026575043910
• UDI-Public: 04026575043910
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K954186
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: 06/30/2018
• Device Model Number: 15-2020/60
• Device Catalogue Number: 15-2020/60
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2013
• 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: 64 YR
• Patient Sex: Male