MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R; KNEE FEMORAL CEMENTED FEMUR

Model Number	02.12.0005R
Health Effect - Clinical Code	Reaction to Medicinal Component of Device (4574)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year and 4 months after the primary surgery, the surgeon observed that the patient had an allergic reaction.The surgeon swapped all devices and implanted sensitin revision knee.The surgery was completed successfully.The patient didn't anti-allergic test before the surgery.
Additional Manufacturer Narrative
Batch review performed on 30-may-2022: lot 1910667: (b)(4) items manufactured and released on 02-apr-2020 expiration date: 2025-mar-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Additional device involved.Batch review performed on 30-may-2022: gmk-sphere 02.12.T3i4r tibial tray fixed cemented size t3-i4 r (k121416) lot 2004184: (b)(4) items manufactured and released on 10-sep-2020.Expiration date: 2025-aug-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Gmk-sphere 02.12.0411fr tibial insert fixed sphere flex size 4/11 mm r (k140826) lot 2000444: (b)(4) items manufactured and released on 26-feb-2020.Expiration date: 2025-feb-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R
• Common Device Name: KNEE FEMORAL CEMENTED FEMUR
• 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: 14684878
• Report Number: 3005180920-2022-00471
• Device Sequence Number: 6636954
• Product Code: JWH
• UDI-Device Identifier: 07630030825866
• UDI-Public: 07630030825866
• Combination Product (Y/N): N
• 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: 2021
• Device Explanted Year: 2022
• 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): 06/14/2022

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: 03/24/2025
• Device Model Number: 02.12.0005R
• Device Catalogue Number: 02.12.0005R
• Device Lot Number: 1910667
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2020
• 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: Female