MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L

Model Number	02.12.0414FL
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 14-july-2020.Lot 1903256: (b)(4) items manufactured and released on 21-jun-2019.Expiration date: 2024-06-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Other devices involved in the event: gmk-sphere 02.12.0005l femoral component sphere cemented # 5 l lot.180953 (k121416).Batch review performed by medacta regualtory affairs department on 14-july-2020.Lot 180953: (b)(4) items manufactured and released on 28-may-2018.Expiration date: 2023-05-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Gmk-sphere 02.07.1204l tibial tray fixed cemented # 4 l lot.181932 (k090988).Batch review performed by medacta regualtory affairs department on 14-july-2020.Lot 181932: (b)(4) items manufactured and released on 17-july-2018.Expiration date: 2023-07-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Gmk-sphere 02.07.0035rp patella resurfacing # 3 lot.182022 (k090988).Batch review performed by medacta regualtory affairs department on 14-july-2020.Lot 182022: (b)(4) items manufactured and released on 16-july-2018.Expiration date: 2023-07-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.
Event or Problem Description
5 months after the previous revision surgery the patient came in due to signs of an infection and the pathogen is unknown the surgeon removed all hardware and implanted a medacta femur and insert with antibiotic cement as an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
On (b)(6) 2020, the surgeon removed the medacta femur and insert and implanted permanent hardware.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM L
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874, CHE; SZ 6874, CHE
• MDR Report Key: 10331236
• Report Number: 3005180920-2020-00458
• Device Sequence Number: 936068
• Product Code: JWH
• UDI-Device Identifier: 07630030826610
• UDI-Public: 07630030826610
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2021

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: No Information
• Device Expiration Date: 06/04/2024
• Device Model Number: 02.12.0414FL
• Device Catalogue Number: 02.12.0414FL
• Device Lot Number: 18108731903256
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 01/07/2021
• 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
• Patient Age: 69 YR