MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L

Catalog Number	02.12.0213FL
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs on 16 february 2018: one year after primary tkr the insert fixation screw got loose in the joint.It was immediately removed and the poly was exchanged.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 batch review performed on 26 february 2018 lot 143213: (b)(4) items manufactured and released on 03 november 2014.Expiration date: 2019-08-31 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.Preliminary investigation based on the pictures of the explanted tibial insert and relative secure fixation screw performed by r&d product manager on 02 march 2018 : tibial insert fixation screw baked out from the insert and was found loosened in the joint after 1 year from primary implantation.Some dents and scratches can be identified on the articular surface of the insert with trace of the threaded part of the screw.The screw looks damaged in its threaded shaft that is plastically deformed.These damages were most likely caused by the screw that, once baked out from the insert, was loosened between the insert and the femoral component and underwent body load.It is not possible to identify any possible root cause for the event analysing the pictures sent.We can only suppose that insufficient tightning torque applied to the screw during fixation could have lead to this unlikely event.The use of a torque limiter screwdriver to tight the screw at 3,5nm is currently mandatory for secure screw fixation.
Event or Problem Description
On (b)(6) 2018 sales representative was informed by the surgeon that the patient came in complaining of pain.The surgeon determined the screw backed out of the poly.Revision surgery performed on (b)(6) 2018 due to screw backed out of the insert.The screw was not implanted using a torque limiting driver.The surgeon implanted a new screw with the insert.He did use a torque driver this time around.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7309745
• Report Number: 3005180920-2018-00116
• Device Sequence Number: 16456446
• Product Code: JWH
• UDI-Device Identifier: 07630030862533
• UDI-Public: 07630030862533
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2018

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: 08/31/2019
• Device Catalogue Number: 02.12.0213FL
• Device Lot Number: 143213
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 03/02/2018
• 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: 48 YR