MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L

Model Number	02.12.0414FL
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 january 2020: lot 150409: (b)(4) items manufactured and released on 20-aug-2015.Expiration date: 2020-06-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event since 2016.Clinical evaluation performed by medical affairs director: less than 3 years after primary cemented tka, the components are removed and exchanged to a constrained device.The reasons are reported to be of twofold origin: the poly insert had not been fully inserted at primary surgery and therefore the knee never worked properly; the mcl was found to be very loose and unable to stabilize an unconstrained knee.This condition may be a consequence of the not-fully-seated poly, but of course it cannot be determined with certainty.The insert-holding screw was probably never fully seated either, as can be surmised looking at the post-op radiograph, where the screw is shown at an angle from the perpendicular to the baseplate.The root cause of this situation should not be sought in a defective device.
Event or Problem Description
The patient came in for a check-up appointment 3 years and 2 months after the primary.The poly dislocated from the tibial tray.As shown in the x-rays, the knee looked maligned, improperly oriented, and mechanically unstable.Everything was revised with a gmk-hinge system and the surgery was completed successfully.
Event or Problem Description
The patient came in for a check-up appointment 3 years and 3 months after the primary.The poly dislocated from the tibial tray.As shown in the x-rays, the knee looked not well aligned, improperly oriented, and mechanically unstable.Everything was revised with a gmk-hinge system and the surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 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: 9738043
• Report Number: 3005180920-2020-00084
• Device Sequence Number: 1815259
• Product Code: JWH
• UDI-Device Identifier: 07630030826610
• UDI-Public: 07630030826610
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2020

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: 06/30/2020
• Device Model Number: 02.12.0414FL
• Device Catalogue Number: 02.12.0414FL
• Device Lot Number: 150409
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 05/20/2020
• 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: 67 YR