MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 5/10 MM L; KNEE TIBIAL INSERT

Model Number	02.12.0510CRL
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10.Aug.2021.Lot 185593: (b)(4) items manufactured and released on 13-oct-2018.Expiration date: 2023-oct-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Other components involved: gmk-sphere 02.12.0026l femoral component sphere cemented size 6+ l (k140826) lot.183451.Lot 183451: (b)(4) items manufactured and released on 18-jul-2018.Expiration date: 2023-june-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot.1909599.Lot 1909599: (b)(4) items manufactured and released on 24-feb-2020.Expiration date: 2025-feb-11.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 a painful tibia and the cause of the painful tibia is unknown.1 year and 2 months after the primary surgery, the surgeon revised all the components and the surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 5/10 MM L
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12391865
• Report Number: 3005180920-2021-00704
• Device Sequence Number: 12033979
• Product Code: JWH
• UDI-Device Identifier: 07630040707619
• UDI-Public: 07630040707619
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181635
• 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): 08/31/2021

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: 10/07/2023
• Device Model Number: 02.12.0510CRL
• Device Catalogue Number: 02.12.0510CRL
• Device Lot Number: 185593
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 08/31/2021
• 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