MAUDE Adverse Event Report: Waldemar Link GmbH & Co. KG Endo-Model SL; Connection Component, Rotating Hinge, medium

Model Number	16-2840/05
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Notified that a revision to an connection component on an endo sl was performed today with dr.(b)(6), and there was difficulty in removing the connection component and there was damage to the femur, insert, bushings and the mechanism, with the screw almost completely worn down.The procedure was extended for approximately 30 minutes.The parts will be returned for the investigation when received."[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: Connection Component, Rotating Hinge, medium
• 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: 50233302
• Report Number: 3004371426-2026-00065
• Device Sequence Number: 18728183
• Product Code: KRO
• UDI-Device Identifier: 04026575359240
• UDI-Public: 04026575359240
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K151008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial
• Report Date (Section B): 07/16/2026

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: 06/30/2025
• Device Model Number: 16-2840/05
• Device Catalogue Number: 16-2840/05
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2020
• 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: Unknown