MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FEMORAL COMPONENT SIZE 3 L; KNEE FEMORAL COMPONENT

Catalog Number	02.09.2603L
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
In the same day after the knee surgery performed on the (b)(6) 2024, a post-op periprosthetic bone fracture was observed.A follow up visit was done on the (b)(6) 2024.According to the revision surgeon, the causes of the postoperative fracture were the patient's osteoporosis and fragility of the anterior femoral cortex, exacerbated by a false route during reaming.The implants were not involved at this stage.Revision of femoral component and extension stem performed successfully.
Additional Manufacturer Narrative
Batch review performed on 07-jun-2024.Lot 2313180: (b)(4) items manufactured and released on 08-nov-2023.Expiration date: 2028-10-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs director: postoperative fracture, on the same day of the tka surgery with a constrained implant, due to the osteoporosis of the patient who also has very small bones which induced a deviation of the reamer.No reason to suspect a defective or malfunctioning device.Additional components involved in the event: batch review performed on 07-jun-2024.Gmk-hinge 02.07.Fcl14065 extension stem - fluted ø 14 l 65 (k120790) lot 2300795: (b)(4) items manufactured and released on 15-jun-2023.Expiration date: 2028-05-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-HINGE FEMORAL COMPONENT SIZE 3 L
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 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: 19614851
• Report Number: 3005180920-2024-00470
• Device Sequence Number: 6197536
• Product Code: KRO
• UDI-Device Identifier: 07630030825439
• UDI-Public: 07630030825439
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130299
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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: 02.09.2603L
• Device Lot Number: 2313180
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2023
• 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; Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Race: White