MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R; KNEE FEMORAL COMPONENT CEMENTED

Model Number	02.12.0024R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2021.On (b)(6) 2021, the patient came in due to signs of an infection and the pathogen was unknown.The surgeon performed a washout, removed all implants, and implanted an antibiotic spacer.The surgery was completed successfully.On (b)(6) 2021, the patient came in and had the spacer removed and permanent hardware implanted.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 24 february 2022: lot 2103463: (b)(4) items manufactured and released on 12-may-2021.Expiration date: 2026-04-28.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 devices involved: gmk-sphere 02.12.0410fr tibial insert fixed sphere flex size 4/10 mm r (k121416) lot.2005227: (b)(4)items manufactured and released on 23-july-2020.Expiration date: 2025-07-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event.Gmk-sphere 02.12.T3i4r tibial tray fixed cemented size t3-i4 r (k121416) lot.2012086: (b)(4) items manufactured and released on 12-may-2021.Expiration date: 2026-04-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R
• Common Device Name: KNEE FEMORAL COMPONENT CEMENTED
• 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: 13770435
• Report Number: 3005180920-2022-00189
• Device Sequence Number: 11718025
• Product Code: JWH
• UDI-Device Identifier: 07630030862403
• UDI-Public: 07630030862403
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 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): 03/15/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2026
• Device Model Number: 02.12.0024R
• Device Catalogue Number: 02.12.0024R
• Device Lot Number: 2103463
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2021
• 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: Unknown