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

Model Number	02.12.0022L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed by medacta regulatory affairs department on 26.04.2021: lot 140723: (b)(4) items manufactured and released on 23.05.2014.Expiration date: 2019-01-31.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 since 2017.Additional devices involved: batch reviews performed by medacta regulatory affairs department on 26.04.2021: gmk-sphere 02.07.1203l tibial tray fixed cemented size 3 l (k090988) lot 148734: (b)(4) items manufactured and released on 17.03.2015.Expiration date: 2020-02-28.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2017.Gmk-sphere 02.12.0310fl tibial insert fixed sphere flex size 3/10 mm l (k121416) lot 147246: (b)(4) items manufactured and released on 13.02.2015.Expiration date: 2019-12-31.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 since 2017.Gmk-sphere 02.07.0034rp patella resurfacing size 2 (k090988) lot 147980: (b)(4) items manufactured and released on 03.03.2015.Expiration date: 2020-01-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event since 2017.Corrected data: on the 27 april 2021 this mdr was sent to the fda test webtrader (https://esgtest.Fda.Gov) for error.Today 9 september 2021 we recognized the error and sent the mdr to fda production webtrader (https://esg.Fda.Gov).
Event or Problem Description
5 years and 9 months after the primary surgery a revision surgery was performed due to signs of an infection and the pathogen is unknown.The surgeon removed all components, made a spacer out of a medacta femur and insert, and applied antibiotic cement.The surgery was completed successfully.On (b)(6) 2021, the patient came in due to signs of an infection and the pathogen is unknown.5 months after the surgery, the surgeon performed a washout, removed the existing spacer, and implanted a new antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2+ L
• Common Device Name: KNEE CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12438433
• Report Number: 3005180920-2021-00333
• Device Sequence Number: 3779464
• Product Code: JWH
• UDI-Device Identifier: 07630030862472
• UDI-Public: 07630030862472
• 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: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2021

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: 01/31/2019
• Device Model Number: 02.12.0022L
• Device Catalogue Number: 02.12.0022L
• Device Lot Number: 140723
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 09/08/2021
• 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