MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM R; KNEE TIBIAL INSERT

Model Number	02.12.0413FR
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07-apr-2022: lot 2000446: (b)(4) items manufactured and released on 12-mar-2020.Expiration date: 2024-02-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional device involved.Batch review performed on 07-apr-2022: gmk-sphere 02.12.T3i4r tibial tray fixed cemented # t3-i4 r (k121416) lot 2013025: (b)(4) items manufactured and released on 12-may-2021.Expiration date: 2026-04-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in reporting pain due to the poly disengaging from the tibial tray as the patient was going up and downstairs.Primary performed in (b)(6) 2021.The surgeon revised the poly and the surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/13 MM R
• Common Device Name: KNEE TIBIAL INSERT
• 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: 14072426
• Report Number: 3005180920-2022-00252
• Device Sequence Number: 2595999
• Product Code: JWH
• UDI-Device Identifier: 07630030862632
• UDI-Public: 07630030862632
• 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: 2021
• Device Explanted Year: 2022
• 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): 04/11/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2024
• Device Model Number: 02.12.0413FR
• Device Catalogue Number: 02.12.0413FR
• Device Lot Number: 2000446
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2020
• 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: Unknown