MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2 L

Model Number	02.12.0002L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 december 2020: lot 163318: (b)(4) items manufactured and released on 26-july-2016.Expiration date: 2021-06-29.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 in the event: gmk-sphere 02.12.0310fl tibial insert fixed sphere flex size 3/10 mm l lot.186012 (k121416).Batch review performed on 09 december 2020: lot 186012: (b)(4) items manufactured and released on 29-nov-2018.Expiration date: 2023-11-19.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.Gmk-sphere 02.07.1203l tibial tray fixed cemented size 3 l lot.1910488 (k090988).Batch review performed on 09 december 2020: lot 1910488: (b)(4) items manufactured and released on 24-mar-2020.Expiration date: 2025-13-12.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
Revision surgery for knee infection 2 months after primary.The surgeon revised the femoral component, tibial tray and poly.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2 L
• Common Device Name: FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11011326
• Report Number: 3005180920-2020-00924
• Device Sequence Number: 4562866
• Product Code: JWH
• UDI-Device Identifier: 07630030825798
• UDI-Public: 07630030825798
• Combination Product (Y/N): Y
• 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: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/29/2021
• Device Model Number: 02.12.0002L
• Device Catalogue Number: 02.12.0002L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 12/15/2020
• 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