MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL; MODULAR STEM, CEMENTED, CONICAL, MALE TAPER

Model Number	15-8522/40
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Periprosthetic fracture (4902)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Fracture of the femoral stem [customer].
Additional Manufacturer Narrative
The production records could not be reviewed as the lot number of the product in question is not available.

• Brand Name: ENDO-MODEL SL
• Common Device Name: MODULAR STEM, CEMENTED, CONICAL, MALE TAPER
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 25547759
• Report Number: 3004371426-2026-00049
• Device Sequence Number: 10731993
• Product Code: KRO
• UDI-Device Identifier: 04026575381777
• UDI-Public: 04026575381777
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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 Model Number: 15-8522/40
• Device Catalogue Number: 15-8522/40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 55 YR
• Patient Sex: Unknown