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

Model Number	16-2849/25
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Positioning Problem (3009)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Recent we did a two site mega-c operation revision indication with big bone loss at the tibia.Tibial replacement on both sites.2 weeks ago, we did a re-fixation of the tibial screws on the left site.We did an analyze of what the purpose of this could have been.With the conclusion after the re-operation that it was bead luck.Because no reasonable reason was occurred.But today we received the same problem at the other site.Old patient, not to have, well motivated, moving with restriction of braces.[customer] update: see the event information from my colleague about the surgery; we opened the knee, just under the patella until we came across the plate.The screws were indeed loose and the lars ligament was torn loose.We removed the screws and checked them.See pictures.The lateral screw had a dent 1/3 from the tip.It was probably in the component up to that point.The medial screw showed no damage.We removed some soft tissue to see if we could make the plate land better and add more turns to the component.Tried to tighten the screw twice.Then this works.Tightened alternately during the last strokes, so alternated between medial and lateral.With the last turn of the lateral screw there suddenly seemed to be room to continue turning.This didn't feel good.Screw broken or windings broken? removed the screw and saw that it was badly damaged by the last attempt.Decided to open the spare component and removed the 2 screws.To be sure, we have now tightened the plate in the bottom position instead of the top (initially) with a new screw both medially and laterally.These were also tightened alternately until we had a good grip.2 fiber wires were fed through the plate before we screwed it in place.After tightening, these fiberwires were used to attach the patellar tendon.[distributor].
Additional Manufacturer Narrative
This is the final supplemental report, the complaint is closed.
Event or Problem Description
Recent we did a two site mega-c operation revision indication with big bone loss at the tibia.Tibial replacement on both sites.2 weeks ago, we did a re-fixation of the tibial screws on the left site.We did an analyze of what the purpose of this could have been.With the conclusion after the re-operation that it was bead luck.Because no reasonable reason was occurred.But today we received the same problem at the other site.Old patient, not to have, well motivated, moving with restriction of braces.[customer].Update: see the event information from my colleague about the surgery; we opened the knee, just under the patella until we came across the plate.The screws were indeed loose and the lars ligament was torn loose.We removed the screws and checked them.See pictures.The lateral screw had a dent 1/3 from the tip.It was probably in the component up to that point.The medial screw showed no damage.We removed some soft tissue to see if we could make the plate land better and add more turns to the component.Tried to tighten the screw twice.Then this works.Tightened alternately during the last strokes, so alternated between medial and lateral.With the last turn of the lateral screw there suddenly seemed to be room to continue turning.This didn't feel good.Screw broken or windings broken? removed the screw and saw that it was badly damaged by the last attempt.Decided to open the spare component and removed the 2 screws.To be sure, we have now tightened the plate in the bottom position instead of the top (initially) with a new screw both medially and laterally.These were also tightened alternately until we had a good grip.2 fiber wires were fed through the plate before we screwed it in place.After tightening, these fiberwires were used to attach the patellar tendon.[distributor].

• Brand Name: ENDO-MODEL SL KNEE JOINT PROSTHESIS
• 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: 19558634
• Report Number: 3004371426-2024-00048
• Device Sequence Number: 14655645
• 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
• Device Explanted 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): 06/04/2024

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: 2332275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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