MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R; KNEE TIBIAL INSERT

Catalog Number	02.12.0411FR
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 july 2019: lot 161957: (b)(4) items manufactured and released on 17-jun-2016.Expiration date: 2021-06-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Clinical evaluation performed on 12 july 2019: 2.5 years after primary cemented total knee arthroplasty, the insert fixation screw got loose in the joint.Screw and liner were removed.During the surgical procedure, visual inspection of the articular surfaces can be performed.In case of no or minimal damage, little or no further consequence should be expected from this event.The cause for self-unscrewing of the insert screw is not known: one possibility is insufficient tightening torque, but other unknown conditions may also play a role.Preliminary investigation performed on 23-july-2019: revision surgery after 2 years and a half from primary due to self-unscrewing and loosening of the insert safety screw.Preliminary investigation based on the picture of the explanted tibial insert and its secure fixation screw.The threaded part of the screw looks partially damaged.This part has been plastically pressed once, backed out from the baseplate, was interposed between the femoral component and the tibia insert and underwent to the body load.Some dents can be noted on the articular surface of the insert that was damaged by the screw.Femoral and tibial tray components have not been explanted, so we can suppose that they have been found in good condition during revision surgery.In case of no or minimal damage, no further consequences should be expected from this event.The most-likely cause for self-unscrewing of the screw is insufficient tightening torque.This screwdriver with a torque limitation (ref.02.07.10.4577; torque limiter screwdriver 3.5 nm), currently mandatory, was not used during the primary surgery.Other unknown factors might also play a role in the event.No further considerations can be done basing on the available information.
Event or Problem Description
About 2 years and a half after primary the surgeon revised the patient knee for liner fixation screw unscrewing.The surgeon removed the screw and revised the insert.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8825504
• Report Number: 3005180920-2019-00610
• Device Sequence Number: 2417174
• Product Code: JWH
• UDI-Device Identifier: 07630030862625
• UDI-Public: 07630030862625
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• 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): 07/25/2019

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: 06/02/2021
• Device Catalogue Number: 02.12.0411FR
• Device Lot Number: 161957
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/25/2019
• 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