MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MEGASYSTEM-C; FEMORAL COMPONENTS,CONDYLAR REPLACEMENTLINK MEGASYSTEM-C,MEDIUM, RIGHT

Model Number	15-8521/10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Unspecified Infection (1930); Medical device site infection (4845)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the history record showed no deviations.The product complies with the specifications valid at the time of manufacture.
Event or Problem Description
Representative (b)(6) reported that in 2 cases for revisions to condylar replacement components, one of the condylar caps was found floating in the joint space upon opening the knee capsule.The case was a revision of the knee for infection where the surgeon was either replacing or removing parts and washing out the knee.The cap was not removed by the surgeon but instead had come dislodged prior to the surgery.In this case, the femoral component remained implanted without the cap and only the poly tibial plateau was swapped.No delay in the procedure.[customer].
Event or Problem Description
Representative (b)(6).Reported that in 2 cases for revisions to condylar replacement components, one of the condylar caps was found floating in the joint space upon opening the knee capsule.The case was a revision of the knee for infection where the surgeon was either replacing or removing parts and washing out the knee.The cap was not removed by the surgeon but instead had come dislodged prior to the surgery.In this case, the femoral component remained implanted without the cap and only the poly tibial plateau was swapped.No delay in the procedure.[customer].
Additional Manufacturer Narrative
The review of the 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.

• Brand Name: MEGASYSTEM-C
• Common Device Name: FEMORAL COMPONENTS,CONDYLAR REPLACEMENTLINK MEGASYSTEM-C,MEDIUM, RIGHT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 22034673
• Report Number: 3004371426-2025-00023
• Device Sequence Number: 20996601
• Product Code: KRO
• UDI-Device Identifier: 04026575381753
• UDI-Public: 04026575381753
• 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: 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): 04/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15-8521/10
• Device Catalogue Number: 15-8521/10
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 68 YR
• Patient Sex: Male