MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L; KNEE TIBIAL TRAY

Catalog Number	02.07.1202L
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17-jul-2023 lot 2248784: (b)(4) items manufactured and released on 12-apr-2023.Expiration date: 2028-03-25.No anomalies found related to the problem.To date, 24 items of the same lot have been sold without any similar reported event during the period of review.Additional device involved: batch review performed on 17-jul-2023 gmk-sphere 02.12.E0211fl tibial insert fixed sphere flex #2/11 mm l e-cross (k202022) lot 2243343: 30 items manufactured and released on 03-jan-2023.Expiration date: 2027-12-13.No anomalies found related to the problem.To date, 10 items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
During the primary knee surgery, when the surgeon was implanting the insert, it would not seat.The surgeon opted to use a mallet against the plastic poly.During this attempt to set the poly with the mallet, the tibia rotated distally and was kicked out from the keel which punctured the tibia resulting in a total fracture.The surgeon put a plate with nine screws as well as a 30 mm extension stem for the fracture.There was a 10-minute delay and the surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L
• 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: 17387762
• Report Number: 3005180920-2023-00566
• Device Sequence Number: 15007735
• Product Code: JWH
• UDI-Device Identifier: 07630030819865
• UDI-Public: 07630030819865
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• 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): 07/25/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02.07.1202L
• Device Lot Number: 2248784
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2023
• 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: Other
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Race: White