MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG ENDO-MODEL KNEE SYSTEM / LINK ENDO-MODEL EVO KNEE; FEMORAL COMPONENTS,CONDYLAR REPLACEMENTLINK® MEGASYSTEM-C,SMALL, LEFT

Model Number	15-8521/08
Medical Device Problem Codes	Fracture (1260); Malposition of Device (2616); Naturally Worn (2988); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)
Date of Event	09/27/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Received information regarding loosening components for a procedure completed on (b)(6) 2023.No event date provided.Awaiting additional information.Updated (b)(6) 2024: revision surgery occurred on (b)(6) 2024.It was confirmed to be a loosening of the hinge.The entire femoral construct was removed, the tibia was left.As noted in revision surgery per (b)(6)., motion was assessed and found to be too much axial and varus/valgus motion with the hinge.The tibial plateau was firmly screwed into the tibia.The thimble was worn down and the doctor wondered if the poly locking detail had worn down on one side.See all images provided.It was also noted at the procedure that the proximal tibia was fractured and healed.[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.This is the final supplemental report, the complaint is closed.
Event or Problem Description
Received information regarding loosening components for a procedure completed on (b)(6) 2023.No event date provided.Awaiting additional information.Updated 2024-10-23: revision surgery occurred on (b)(6) 2024.It was confirmed to be a loosening of the hinge.The entire femoral construct was removed, the tibia was left.As noted in revision surgery per j.T., motion was assessed and found to be too much axial and varus/valgus motion with the hinge.The tibial plateau was firmly screwed into the tibia.The thimble was worn down and the doctor wondered if the poly locking detail had worn down on one side.See all images provided.It was also noted at the procedure that the proximal tibia was fractured and healed.[customer].

• Brand Name: ENDO-MODEL KNEE SYSTEM / LINK ENDO-MODEL EVO KNEE
• Common Device Name: FEMORAL COMPONENTS,CONDYLAR REPLACEMENTLINK® MEGASYSTEM-C,SMALL, LEFT
• 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: 20544090
• Report Number: 3004371426-2024-00072
• Device Sequence Number: 7392058
• Product Code: KRO
• UDI-Device Identifier: 04026575383214
• UDI-Public: 04026575383214
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K143179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 09/30/2024

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: 15-8521/08
• Device Catalogue Number: 15-8521/08
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• 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 Age: 56 YR
• Patient Sex: Male