MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L TINBN COATED; KNEE TIBIAL TRAY

Catalog Number	02.07.2803L
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10-may-2024.Lot 2339295: (b)(4) items manufactured and released on 15-feb-2024.Expiration date: 2029-01-22.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.
Event or Problem Description
During the primary knee surgery, a tibial bone fracture occurred while implanting the tibial tray.In order to complete the case, the surgeon prepared the bone for a 11x65 tibial stem and then reimplanted tray with the stem attached.The surgeon also added two 4.0 cancellous screws to repair the fracture site.There was no delay, and the surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L TINBN COATED
• Common Device Name: KNEE TIBIAL TRAY
• 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: 19380483
• Report Number: 3005180920-2024-00367
• Device Sequence Number: 7529199
• Product Code: JWH
• UDI-Device Identifier: 07630030821806
• UDI-Public: 07630030821806
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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: 02.07.2803L
• Device Lot Number: 2339295
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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