MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 4 L; KNEE FEMORAL COMPONENT

Catalog Number	02.09.2604L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to broken condyle bone and femoral component loosening at about 9 months from the primary.The surgeon revised the femoral component, the extension stem and the liner as per standard procedure.
Additional Manufacturer Narrative
Batch review performed on 29 april 2024: lot 2116298: (b)(4) items manufactured and released on 13-apr-2022.Expiration date: 2027-03-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs director: few months after revision tka with a constrained device, the bone of the medial femoral condyle breaks and therefore a new component, provided with a bone augment, is needed.There is no mention of traumatic events in the report, so we cannot establish the cause of the bone fracture, but there is no reason to suspect that this was due to the malfunctioning of the implanted device.

• Brand Name: GMK-HINGE FEMORAL COMPONENT SIZE 4 L
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; CH 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19236562
• Report Number: 3005180920-2024-00281
• Device Sequence Number: 20832241
• Product Code: KRO
• UDI-Device Identifier: 07630030825453
• UDI-Public: 07630030825453
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K130299
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2024

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 Catalogue Number: 02.09.2604L
• Device Lot Number: 2116298
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2022
• 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: 69 YR
• Patient Sex: Female