MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 1 R; KNEE CEMENTED TIBIAL TRAY

Model Number	02.07.1201R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year 2 months after the primary, the patient came in reporting pain and the cause is unknown.The surgeon revised all components and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 12 june 2023.Lot 2101281: (b)(4) items manufactured and released on 23-june-2021.Expiration date: 2026-06-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional implants involved: batch review performed on 12 june 2023 on gmk-sphere 02.12.0002r femoral component sphere cemented size 2 r (k121416) lot.2009123 lot 2009123: (b)(4) items manufactured and released on 03-nov-2020.Expiration date: 2025-10-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Batch review performed on 12 june 2023 on gmk-sphere 02.12.0112fr tibial insert fixed sphere flex size 1/12 mm r (k121416) lot.189029 lot 189029: (b)(4) items manufactured and released on 04-march-2019.Expiration date: 2024-02-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 1 R
• Common Device Name: KNEE CEMENTED TIBIAL TRAY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17215661
• Report Number: 3005180920-2023-00475
• Device Sequence Number: 3022567
• Product Code: JWH
• UDI-Device Identifier: 07630030819858
• UDI-Public: 07630030819858
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2023

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: 06/10/2026
• Device Model Number: 02.07.1201R
• Device Catalogue Number: 02.07.1201R
• Device Lot Number: 2101281
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2021
• 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: Female