MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG Endo-Model® Sled; Endo-Model® Sled,Tibial Plat., anat.,metal-backed,27,5 x 55 mm x 9 mm

Model Number	15-2030/10
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/31/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Device revision "[patient]".

• Brand Name: Endo-Model® Sled
• Common Device Name: Endo-Model® Sled,Tibial Plat., anat.,metal-backed,27,5 x 55 mm x 9 mm
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 24629345
• Report Number: 3004371426-2026-00022
• Device Sequence Number: 15707037
• Product Code: HSX
• UDI-Device Identifier: 04026575044146
• UDI-Public: 04026575044146
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K954186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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: 05/31/2010
• Device Model Number: 15-2030/10
• Device Catalogue Number: 15-2030/10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2005
• 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 Sex: Unknown