MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0411FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L

Model Number	02.12.0411FL
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 november 2021: lot 176154: (b)(4) items manufactured and released on 08-jan-2018.Expiration date: 2022-12-13.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.Other devices involved: batch review performed on 30 november 2021: gmk-sphere 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot 1907819: (b)(4) items manufactured and released on 11-dec-2019.Expiration date: 2024-11-30.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.
Event or Problem Description
The patient came in for a post-op appointment and post-op x-rays indicated that the poly had disengaged from the tibial tray and the cause is unknown.The surgeon revised the insert 11 months after primary and the surgery was completed successfully.The liner screw was not used in primary surgery.

• Brand Name: GMK-SPHERE 02.12.0411FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12975553
• Report Number: 3005180920-2021-00957
• Device Sequence Number: 4291682
• Product Code: JWH
• UDI-Device Identifier: 07630030862601
• UDI-Public: 07630030862601
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2021

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: 12/13/2022
• Device Model Number: 02.12.0411FL
• Device Catalogue Number: 02.12.0411FL
• Device Lot Number: 176154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male