MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE 02.09.0120H FIXED TIBIAL INSERT SIZE 1/20MM; KNEE TIBIAL INSERT

Model Number	02.09.0120H
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 january 2023: lot: 124930ar: (b)(4) items manufactured and released on 04-mar-2014.Expiration date: 2017-10-31.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.Clinical evaluation performed by medical affairs director: 8 years after revision tka made using a constrained device, the screw that holds the femoral component to the metal post in the center of the tibia got loose.The quality of the images supplied is extremely poor and little can be extracted from them.However, the loosening of the screw,according to the report, did not create any damage to the artificial articulation and it was sufficient to tighten the screw again - of course, this implied one more surgery.The causes for unexpected unscrewing of the component may be of different kinds: the most probable one, reproduced in laboratory simulations, is insufficient tightening torque applied at index surgery.For this reason, a torque-limiting screwdriver is part of the instrument set.
Event or Problem Description
Knee dislocation at 7 years and 10 months post-primary, post screw found loose in the knee.Only the liner was swapped.

• Brand Name: GMK-HINGE 02.09.0120H FIXED TIBIAL INSERT SIZE 1/20MM
• 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: 16285478
• Report Number: 3005180920-2023-00008
• Device Sequence Number: 11994351
• Product Code: KRO
• UDI-Device Identifier: 07630030825019
• UDI-Public: 07630030825019
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• 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): 02/02/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 02.09.0120H
• Device Catalogue Number: 02.09.0120H
• Device Lot Number: 124930AR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2014
• 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