MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 2/17MM; KNEE TIBIAL INSERT

Model Number	02.09.0217H
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 september 2022.Lot 181575: (b)(4) items manufactured and released on 28-june-2018.Expiration date: 2023-06-11.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: approximately 6 months after implantation of a constrained tka, the radiographic control shows a broken insert screw.According to report, the patient reports pain, but it is not clear how and if such pain is related to the broken screw: the xray image, of very poor quality, shows radiolucency in the tibia near the implant, which in our opinion is a more probable cause of pain that will likely require revision.The size of the wedges under the tibial plateau is possibly too small, and there may be insufficient cortical contact.No xray history was supplied to try to understand when the fracture of the screw took place, therefore we cannot determine the causes for the adverse event.Most probably, the tibial component needs to be revised independently from the fractured screw.
Event or Problem Description
The patient came in for a post-op appointment at about 6 months after the primary and the x-rays indicated that the fixation screw of the gmk-hinge tibial insert was broken.During the primary surgery, the insert screw was tightened successfully using a 3nm torque.Revision surgery not yet performed.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 2/17MM
• Common Device Name: KNEE TIBIAL INSERT
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15483656
• Report Number: 3005180920-2022-00730
• Device Sequence Number: 1905343
• Product Code: KRO
• UDI-Device Identifier: 07630030825071
• UDI-Public: 07630030825071
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 09/26/2022

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 Expiration Date: 06/11/2023
• Device Model Number: 02.09.0217H
• Device Catalogue Number: 02.09.0217H
• Device Lot Number: 181575
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2018
• 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: Unknown