MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R

Catalog Number	02.12.0212FR
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager on 04 may 2018: 2 years and 8 months after primary tka in an elderly ((b)(6) year old) (b)(6) kg lady, the insert fixation screw was found partially backed out.It was immediately removed with an arthroscopic operation.No consequence should be expected for the absence of the screw in the future life of the implant.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 22 may 2018; lot 141801: (b)(4) items manufactured and released on 22 may 2014.Expiration date: 2019-03-31 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.Visual inspection performed by r&d product manager on 23 may 2018 of the explanted insert fixation screw: loosened insert safety screw occurred about 2 years and a half after primary surgery.Screw has been already removed by arthroscopy.No damages or signs of usage can be seen on the head and the threaded part of the screw.It was possible that, once backed out from the baseplate, the screw was not interposed between the femoral component and the tibia insert and didn't undergo to the body load.No other components have been removed, so we can suppose that they have been found in good condition during arthroscopy to remove the screw.The most-likely cause for self-unscrewing of the screw, was insufficient tightening torque during fixation.Using a screwdriver provided with a torque limitation (ref.02.07.10.4577; torque limiter screwdriver 3.5 nm - now mandatory) would prevent this event.But other unknown factors might also play a role in the event.No further considerations can be done with the information available.
Event or Problem Description
On (b)(6) 2018 we were informed that a patient had presented to clinic with anterior knee pain.X ray showed partial back out of the tibial insert screw.On (b)(6) 2018 surgeon arthroscopic removed the inlay locking screw due to unscrewing.
Additional Manufacturer Narrative
On 15 june 2018 we were informed that the torque limiter was not used in primary surgery.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/12 MM R
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7536828
• Report Number: 3005180920-2018-00354
• Device Sequence Number: 19190778
• Product Code: JWH
• UDI-Device Identifier: 07630030826184
• UDI-Public: 07630030826184
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2018

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: 03/31/2019
• Device Catalogue Number: 02.12.0212FR
• Device Lot Number: 141801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 07/13/2018
• 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: 84 YR