MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L; KNEE CEMENTED FEMUR

Model Number	02.12.0006L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/08/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 march 2022: lot 2105260: (b)(4).Expiration date: 2026-06-14.No anomalies found related to the problem.(b)(4).Additional devices involved: batch reviews performed on 18 march 2022: gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot 2104561: (b)(4).Expiration date: 2026-07-26.No anomalies found related to the problem.To date, (b)(4).Gmk-sphere 02.12.0510fl tibial insert fixed sphere flex size 5/10 mm l (k121416) lot 2104752: (b)(4).Expiration date: 2026-06-01.No anomalies found related to the problem.(b)(4).
Event or Problem Description
The patient came in due to signs of an infection after about four months from the primary, the pathogen is unknown.The surgeon performed a washout and revised all implants.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L
• Common Device Name: KNEE 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: 14021282
• Report Number: 3005180920-2022-00234
• Device Sequence Number: 5938246
• Product Code: JWH
• UDI-Device Identifier: 07630030825873
• UDI-Public: 07630030825873
• 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): 04/06/2022

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: 06/14/2026
• Device Model Number: 02.12.0006L
• Device Catalogue Number: 02.12.0006L
• Device Lot Number: 2105260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2021
• 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