MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG ENDO-MODEL SL; PROXIMAL TIBIAMOD. REPL. COMP. F.LINK® KNEE-SYSTEM SLMEDIUM 65 MM

Model Number	16-2849/25
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Last month we did a case with a lady who received on both sides a proximal tibia replacement.The surgeries went well but today i received this foto.The screw which fixates the patella tendon to the prosthesis came out.The doctor want to replace it on 17th of may.For this case we need the right screw and if possible a bit longer than the current one.[customer].
Additional Manufacturer Narrative
This is the final supplemental report, the complaint is closed.
Event or Problem Description
Last month we did a case with a lady who received on both sides a proximal tibia replacement.The surgeries went well but today i received this foto.The screw which fixates the patella tendon to the prosthesis came out.The doctor want to replace it on (b)(6).For this case we need the right screw and if possible a bit longer than the current one.Update: original operation date: (b)(6), additional operation date; (b)(6).Recent we did a two site mega-c operation revision indication with big bone loss at the tibia.Tibial replacement on both sites.This was 2 and 3 months ago.2 weeks ago, we did a re-fixation of the tibial screws on the left side.No new screws were used, just a tighning of the screws.[customer].

• Brand Name: ENDO-MODEL SL
• Common Device Name: PROXIMAL TIBIAMOD. REPL. COMP. F.LINK® KNEE-SYSTEM SLMEDIUM 65 MM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO.KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 19493078
• Report Number: 3004371426-2024-00046
• Device Sequence Number: 7089612
• Product Code: KRO
• UDI-Device Identifier: 04026575383375
• UDI-Public: 04026575383375
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K151008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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: 16-2849/25
• Device Catalogue Number: 16-2849/25
• Device Lot Number: 2322011
• 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: 05/08/2024
• Supplement Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 06/08/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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