MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG ENDO-MODEL SL KNEE JOINT PROSTHESIS; CONNECTION COMPONENTROTATIONAL VERSION,SMALL

Model Number	16-2840/02
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Notified by (b)(6) on 2024-08-14, that a revision of a disassociated connection component originally implanted on (b)(6) 2018, was performed by dr.(b)(6).On (b)(6) 2024.Images included, one showing explanted components with set screw that is proud and notified that this is how it looked upon removal.Revision surgery was successful.[customer].
Additional Manufacturer Narrative
This is the final supplemental report, the complaint is closed.
Event or Problem Description
Notified by (b)(6) on (b)(6) 2024, that a revision of a disassociated connection component originally implanted on (b)(6) 2018, was performed by dr.(b)(6).On (b)(6) 2024.Images included, one showing explanted components with set screw that is proud and notified that this is how it looked upon removal.Revision surgery was successful.[customer].

• Brand Name: ENDO-MODEL SL KNEE JOINT PROSTHESIS
• Common Device Name: CONNECTION COMPONENTROTATIONAL VERSION,SMALL
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO.KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 20142862
• Report Number: 3004371426-2024-00064
• Device Sequence Number: 19649703
• Product Code: KRO
• UDI-Device Identifier: 04026575359233
• UDI-Public: 04026575359233
• 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: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 16-2840/02
• Device Catalogue Number: 16-2840/02
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2017
• 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: Female