MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/17MM; KNEE TIBIAL INSERT

Model Number	02.09.0417H
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery at about 4 months for yoke screw (post screw) loosening.A new pivot with pivot screw was implanted successfully using the torque wrench.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022: lot 1900729: (b)(4) items manufactured and released on (b)(6) 2019.Expiration date: 2024-04-22.No anomalies found related to the problem.To date, (b)(4) 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: few months after primary tkr with a constrained device, the patient feels apin and the radiographic analysis shows a loose screw in the joint.The patient is taken to surgery and the screw replaced with a new one.It is possible that the torque wrench had not been used in primary surgery: this may lead to insufficient torque being applied to tighten the screw, and in turn this is a possible cause for self-unscrewing of the fixation screws, which could be reproduced in the laboratory.No further clinical consequence is to be expected.Visual inspection performed by r&d knee manager: revision surgery of a gmk hinge tibial insert performed 3 months after the primary surgery because hinge post screw was found not loosened in the joint.The hinge post extension with its screw have been sent back to medacta for inspection.Tibial insert and its secure screw have not been sent back.The screw looks intact, with no signs of damage.It is still possible to completely engage the screw into the post extension.No other elements potentially relevant for the event can be noted on the returned parts.From visual inspection it is not possible to determine the root cause for this unlikely and undesired event. the usage of the torque limiting screwdriver, mandatory for this application, has not been confirmed.We can only suppose that the hinge screw was not properly secured or that the hinge post was not well connected to the femoral component before its fixation with the screw.One of these could had led the loosening of the screw in the joint; but there is no evidence in support of these hypothesis.  reason for unscrewing remains unknown.From visual inspection there is no evidence that the event is related to a faulty device.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 4/17MM
• 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: 16022747
• Report Number: 3005180920-2022-00939
• Device Sequence Number: 6997794
• Product Code: KRO
• UDI-Device Identifier: 07630030825217
• UDI-Public: 07630030825217
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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): 12/21/2022

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: 04/22/2024
• Device Model Number: 02.09.0417H
• Device Catalogue Number: 02.09.0417H
• Device Lot Number: 1900729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2022
• Initial Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2019
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White