MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED # T3-I4 L; KNEE TIBIAL TRAY

Catalog Number	02.12.T3I4L
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04 december 2018.Lot 164018: (b)(4) items manufactured and released on 05 september 2016.Expiration date: 2021-08-23.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 by medical affairs director on dec 7, 2018: anterior tibial tray subsidence in cemented tka 1, 5 years after primary operation.The reasons may be insufficient covering of the tibial plateau, perhaps due to a particular anatomical shape, or secondary mechanical deficiency of the supporting bone.This problem cannot be ascribed to an implant malfunction.
Event or Problem Description
The patient came in 1 year and 7 months after primary surgery due to instability, caused by the subsidence of the tibial tray.The surgeon revised the tibial tray and insert.The surgery was completed successfully.
Additional Manufacturer Narrative
On january 30, 2019 the surgeon informed us that the patient had severe osteoporosis: as a consequence, the medical affairs director updated his clinical evaluation as follows: anterior tibial tray subsidence in cemented tka 1.5 years after primary operation.The reasons may be insufficient covering of the tibial plateau, perhaps due to a particular anatomical shape or secondary mechanical deficiency of the supporting bone, reportedly due to intervened severe osteoporosis.This problem cannot be ascribed to an implant malfunction.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED # T3-I4 L
• Common Device Name: KNEE TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8141705
• Report Number: 3005180920-2018-00976
• Device Sequence Number: 11199037
• Product Code: JWH
• UDI-Device Identifier: 07630030827136
• UDI-Public: 07630030827136
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

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: 08/23/2021
• Device Catalogue Number: 02.12.T3I4L
• Device Lot Number: 164018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 03/01/2019
• 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