MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2+ L

Model Number	02.12.0022L
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 26 october 2020: lot 1906040: (b)(4) items manufactured and released on 22-oct-2019.Expiration date: 2024-10-12.No anomalies found related to the problem.To date, 35 items of the same lot have been sold without any similar reported event.Other devices involved in the event: gmk-sphere 02.12.0211fl tibial insert fixed sphere flex #2/11 mm l lot.187207 (k140826), batch review performed by medacta regulatory affairs department on 26 october 2020: lot 187207 : (b)(4) items manufactured and released on 29-nov-2018.Expiration date: 2023-11-15.No anomalies found related to the problem.To date, 31 items of the same lot have been sold without any similar reported event.Gmk-sphere 02.07.1202l tibial tray fixed cemented # 2 l lot.1907808 (k090988), batch review performed by medacta regulatory affairs department on 26 october 2020: lot 1907808: (b)(4) items manufactured and released on 19-dic-2019.Expiration date: 2024-12-10.No anomalies found related to the problem.To date, 36 items of the same lot have been sold without any similar reported event.Gmk-sphere 02.07.0033rp patella resurfacing s1 lot.1906277 (k090988), batch review performed by medacta regulatory affairs department on 26 october 2020: lot 1906277: (b)(4) items manufactured and released on 17-sep-2019.Expiration date: 2024-09-02.No anomalies found related to the problem.To date, 189 items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in 4 months after previous revision surgery due to signs of an infection and the pathogen is escherichia coli.The surgeon performed a washout and revised all implants.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2+ L
• Common Device Name: FEMORAL COMPONENT CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10822492
• Report Number: 3005180920-2020-00794
• Device Sequence Number: 19567615
• Product Code: JWH
• UDI-Device Identifier: 07630030862472
• UDI-Public: 07630030862472
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• 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: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2020

1 Device 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: 10/12/2024
• Device Model Number: 02.12.0022L
• Device Catalogue Number: 02.12.0022L
• Device Lot Number: 1906040
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No