MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/23MM; KNEE TIBIAL INSERT

Catalog Number	02.09.0423H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on "2410" september 2019.Lot 143831: (b)(4) items manufactured and released on 22-sept-2014.Expiration date: 2019-07-30.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been already sold without any similar reported event.Clinical evaluation performed by medical affairs director two years after revision tka with constrained prosthesis the screw holding the pe insert is found to be broken, although the insert is regularly in place.Surgery is performed to replace the polyethylene component.The report does not say whether a new screw could be used.We cannot determine if the screw got broken at surgery or later on.Lack of information does not allow a fully meaningful analysis to be performed.There are no elements that let us understand how and why the screw fractured.
Event or Problem Description
The patient came in for a follow-up appointment and had x-rays taken.The surgeon observed that the screw that holds the tibial insert to the tibial tray was broken.Two years after primary surgery, the surgeon revised the poly and the broken screw.The patient did not complain of pain or discomfort before the revision surgery.The surgery was completed successfully.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 4/23MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9196343
• Report Number: 3005180920-2019-00856
• Device Sequence Number: 10874884
• Product Code: KRO
• UDI-Device Identifier: 07630030825231
• UDI-Public: 07630030825231
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2019

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: 07/30/2019
• Device Catalogue Number: 02.09.0423H
• Device Lot Number: 143831
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention