MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL KNEE PROSTHESIS SYSTEM

Model Number	16-2840/05
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Notified on 3/6/2024 by representative m.Plate, that on (b)(6) 2024, dr.M.Performed a revision surgery for an endo sl that had a disassociated connection component.At review of pre-op x-rays it was still unclear as to the issue.When opened, it was clear that the components were disassociated.All the disassociated pieces were removed and this extended the surgery approximately 30 minutes.

• Brand Name: ENDO-MODEL SL KNEE PROSTHESIS SYSTEM
• Common Device Name: ENDO-MODEL SL KNEE PROSTHESIS SYSTEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 18880866
• Report Number: 3006721341-2024-00005
• Device Sequence Number: 21146224
• Product Code: KRO
• UDI-Device Identifier: 04026575359240
• UDI-Public: 04026575359240
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2024
• Report Date (Section F): 03/06/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 16-2840/05
• Device Catalogue Number: 16-2840/05
• Device Lot Number: 160602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/01/2024
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male