MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL M; FEMORAL TRIAL, RIGHT, S, STAINLESS STEEL

Model Number	15-3234/07
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record is being reviewed.
Event or Problem Description
Small right femoral trials in stock were found to have the incorrect mark for the size feature; the parts are marked with an l designating left.All the other laser marking on the trials is correct, the parts are small rights, and the labeling reflects small right.[customer].

• Brand Name: ENDO-MODEL M
• Common Device Name: FEMORAL TRIAL, RIGHT, S, STAINLESS STEEL
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 24330065
• Report Number: 3004371426-2026-00013
• Device Sequence Number: 13197787
• Product Code: HWT
• UDI-Device Identifier: 04026575363964
• UDI-Public: 04026575363964
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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 Model Number: 15-3234/07
• Device Catalogue Number: 15-3234/07
• Device Lot Number: C534017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown