MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM; KNEE TIBIAL INSERT

Model Number	02.09.0214H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: 5 years after a complex knee revision case, the inlay fixation screw is found broken at the standard follow up examination.No clinical symptoms were perceived by the patient; the artificial joint was still working properly.For this reason, in order to prevent possible future complications, the patient is reoperated and screw and inlay are replaced.The reasons for the screw fracture are unknown; we also do not know at what time the fracture occurred.It is possible that the screw was overstressed at the time of surgery, but of course this is only a hypothesis with no evidence to support it.The reasons leading to screw fracture cannot be determined with the information at hand.Preliminary investigation performed by r&d manager revision surgery of a gmk hinge implant after 5 years of implantation due to breakage of the tibial insert secure screw.From x-rays, the screw was found broken and loosened in the joint.From picture of the explanted components, the screw looks broken in its threaded shaft, at the level of the cantilevered portion of the screw when fixed in the baseplate.It is not possible to determine the root cause of the event; traumatic event and / or excessive tightening torque and / or increased instability of the patient from primary surgery producing unexpected loads in the joint could have played a role in the event, but this remains just an hypothesis not confirmed.Visual inspection performed by r&d manager: revision surgery of a gmk hinge implant after 5 years of implantation due to breakage of the tibial insert secure screw.From visual inspection of the explanted component, we can confirm what already stated in the preliminary investigation.The screw is broken in its threaded shaft, at the level of the cantilevered portion of the screw when fixed in the baseplate.It is not possible to determine the root cause of the event; traumatic event and / or excessive tightening torque and / or increased instability of the patient from primary surgery producing unexpected loads in the joint could have played a role in the event, but this remains just an hypothesis not confirmed.Batch review performed on 14 may 2021 lot 143009: 25 items manufactured and released on 16-july-2014.Expiration date: 2019-06-30.No anomalies found related to the problem to date, 23 items of the same lot have been already sold, 2 items are in quarantine warehouse expired products.Two other similar events have been reported on this lot.
Event or Problem Description
Revision surgery performed 5 years after the primary due to tibial insert screw breakage.The surgeon removed the broken screw and swapped the liner.The surgery was completed successfully.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 2/14MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11900239
• Report Number: 3005180920-2021-00440
• Device Sequence Number: 16467589
• Product Code: KRO
• UDI-Device Identifier: 07630030825064
• UDI-Public: 07630030825064
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• 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): 05/28/2021

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 Expiration Date: 06/30/2019
• Device Model Number: 02.09.0214H
• Device Catalogue Number: 02.09.0214H
• Device Lot Number: 143009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 05/28/2021
• 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
• Patient Age: 63 YR