MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R; KNEE IMPLANT: TIBIAL INSERT FLEX

Model Number	02.12.0411FR
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14-feb-2020: lot 183058: (b)(4) items manufactured and released on 02-jul-2018.Expiration date: 06-18-2023.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.Another implants involved: gmk-sphere 02.07.1204r tibial tray fixed cemented size 4 r (k090988) lot.1810474.Batch reviews performed on 14-feb-2020: lot 1810474: (b)(4) items manufactured and released on 06-mar-2019.Expiration date: 2024-02-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.Another implants involved: gmk-sphere 02.12.0024r femoral component sphere cemented size 4+ r (k140826) lot.183461.Batch reviews performed on 14-feb-2020: lot 183461: (b)(4) items manufactured and released on 30-aug-2018.Expiration date: 20.08.2023.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.Another implants involved: gmk-sphere 02.07.F11066 primary extension stem ø11mm / l 65 mm (k090988) lot.1900598.Batch reviews performed on 14-feb-2020: lot 1900598: (b)(4) items manufactured and released on 14-may-2019.Expiration date: 01.05.2024.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.Another implants involved:gmk-sphere 02.07.0034rp patella resurfacing size 2 (k090988) lot.1903586.Batch reviews performed on 14-feb-2020: lot 1903586: (b)(4) items manufactured and released on 03-jul-2019.Expiration date: 16.06.2024.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with one similar reported event.
Event or Problem Description
The patient came in due to signs of an infection 3 months after the primary, the pathogen is unknown.The surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R
• Common Device Name: KNEE IMPLANT: TIBIAL INSERT FLEX
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9786033
• Report Number: 3005180920-2020-00117
• Device Sequence Number: 14096860
• Product Code: JWH
• UDI-Device Identifier: 07630030862625
• UDI-Public: 07630030862625
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/18/2023
• Device Model Number: 02.12.0411FR
• Device Catalogue Number: 02.12.0411FR
• Device Lot Number: 183058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 03/04/2020
• 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