MAUDE Adverse Event Report: Waldemar Link GmbH & Co. KG Endo-Model SL; Modular Stem, cemented, conical, male taper

Model Number	15-8522/44
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Disassembly of arthrodesis module from femoral stem "[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.

• 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: 50219104
• Report Number: 3004371426-2026-00063
• Device Sequence Number: 10270825
• Product Code: KRO
• UDI-Device Identifier: 04026575381746
• UDI-Public: 04026575381746
• 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: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2026

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: 01/31/2025
• Device Model Number: 15-8522/44
• Device Catalogue Number: 15-8522/44
• Device Lot Number: 1945327
• 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: 07/13/2026
• Initial Report FDA Received Date: 08/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2020
• 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: Male