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

Model Number	02.12.0006L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 november 2020: lot 1908834: (b)(4) items manufactured and released on 19-nov-2019.Expiration date: 2024-11-06.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.Additional devices involved: batch reviews performed on 06 november 2020: gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot 1907821: (b)(4) items manufactured and released on 14-jan-2020.Expiration date: 2024-12-10.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 02.12.0510fl tibial insert fixed sphere flex size 5/10 mm l (k121416) lot 1904543: (b)(4) items manufactured and released on 14-jul-2019.Expiration date: 2024-06-29.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.
Event or Problem Description
The patient came in, 4 months after primary surgery, due to signs of infection and the pathogen is unknown.The surgeon removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 6 L
• Common Device Name: KNEE CEMENTED FEMUR
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10895939
• Report Number: 3005180920-2020-00834
• Device Sequence Number: 14260030
• 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: 2020
• Device Explanted Year: 2020
• 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): 11/24/2020

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: 11/06/2024
• Device Model Number: 02.12.0006L
• Device Catalogue Number: 02.12.0006L
• Device Lot Number: 1908834
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/24/2020
• 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