MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/12 MM L; KNEE TIBIAL INSERT

Model Number	02.12.0412FL
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 january 2021: lot 1908770: (b)(4) items manufactured and released on 7-nov-2019.Expiration date: 2024-10-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without other similar events.Additional devices involved: batch reviews performed on 14 january 2021: gmk-sphere 02.12.0025l femoral component sphere cemented # 5+ l (k140826) lot 2000511: (b)(4) items manufactured and released on 29-may-2020.Expiration date: 2025-05-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without other similar events.Gmk-sphere 02.07.1204l tibial tray fixed cemented # 4 l (k090988) lot 1909596: (b)(4) items manufactured and released on 29-apr-2020.Expiration date: 2025-04-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without other similar events.
Event or Problem Description
1 month after the previous revision surgery the patient came in due to signs of infection and the pathogen is unknown.The surgeon removed all components and implanted medacta femur and tibia with antibiotic cement to act as a spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Permanent hardware was implanted today(b)(6) 2021 for this patient after the spacer was explanted.Permanent hardware was implanted on (b)(6) 2021 for this patient after the spacer was explanted.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/12 MM L
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11271431
• Report Number: 3005180920-2021-00079
• Device Sequence Number: 3842779
• Product Code: JWH
• UDI-Device Identifier: 07630030826573
• UDI-Public: 07630030826573
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: 10/15/2024
• Device Model Number: 02.12.0412FL
• Device Catalogue Number: 02.12.0412FL
• Device Lot Number: 1908770
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 08/25/2021
• 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