MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 5/14MM; POLYETHYLENE KNEE INSERT

Catalog Number	02.09.0514H
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 april 2019: lot 171453: (b)(4) items manufactured and released on 10-may-2017.Expiration date: 2022-04-25.No anomalies found related to the problem.To date, no other items of the same lot have been already sold.Preliminary investigation performed by r&d project manager: revision surgery after less than 2 months from primary surgery of a gmk hinge implant.Event description reports that the event was caused by breakage of the hinge post secure screw.From the picture of the explanted components, the screw seems to be broken in its threaded shaft (5 threads remaining of the 8 of an unbroken screw).The other part of the screw is not visible in the picture; it probably remained screwed into the hinge post.Tibial insert secure screw looks intact and properly siting in the baseplate at the time of the revision surgery.It is difficult to understand which could be the cause of this unlikely and undesired event.We can only suppose that the event was caused: by excessive tightening torque applied to the screw that secures the hinge post to the femoral component during assembling.The usage of a torque limiting screwdriver, available in every revision instrument set, is mandatory to secure the fixation of the stem with the femoral component by the screw.By insufficient tightening torque applied to the screw during fixation; this could have caused the mobilization of the hinge post and resulting unpredictable loads acting on the screw.Because the screw was somehow hit during assembling we don't know if the torque limiting screwdriver was used or not, and in case, if it was used correctly.So, all of the considerations above remain only suppositions.- no further considerations can be done from the picture enclosed.
Event or Problem Description
On the (b)(6) 2019 we were informed about a revision surgery planned and performed on the (b)(6) 2019.The revision surgery was two months after the primary due to the post screw breakage.The screw was found outside the implant causing pain to the patient.Revision surgery completed successfully (insert revision).
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director: fracture of an internal connection screw in a revision constrained tka: the fracture of this screw is an extremely rare event and we cannot imagine a clinical condition compatible with the patient xrays that may have led to such event.That screw, when properly implanted, should normally work under axial loads and it is very difficult to imagine a situation that may have led to its fracture.The clinical investigation is unable to supply any useful contribution.
Additional Manufacturer Narrative
On (b)(6) 2019 we received the liner and the locking screw involved in the event.Visual inspection performed by r&d knee manager: preliminary investigation confirmed.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 5/14MM
• Common Device Name: POLYETHYLENE KNEE INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8577871
• Report Number: 3005180920-2019-00344
• Device Sequence Number: 16692340
• Product Code: KRO
• UDI-Device Identifier: 07630030825279
• UDI-Public: 07630030825279
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130299
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2019

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: 04/25/2022
• Device Catalogue Number: 02.09.0514H
• Device Lot Number: 171453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 04/04/2019; 04/04/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 05/29/2019; 10/17/2019
• 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
• Patient Age: 55 YR