MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5+ R; CEMENTED FEMORAL COMPONENT

Model Number	02.12.0025R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 may 2022: lot 2101944: (b)(4) items manufactured and released on 09-apr-2021.Expiration date: 2026-03-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional implants involved: batch review performed on 30 may 2022: gmk-sphere 02.12.0511fr tibial insert fixed sphere flex size 5/11 mm r (k140826) lot.2011063: (b)(4) items manufactured and released on 14-dec-2020.Expiration date: 2025-11-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported.Batch review performed on 30 may 2022: gmk-sphere 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot.2011764: (b)(4) items manufactured and released on 18-mar-2021.Expiration date: 2026-03-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Batch review performed on 30 may 2022: gmk-sphere 02.07.0035rp patella resurfacing size 3 (k090988) lot.2102489: (b)(4) items manufactured and released on 08-apr-2021.Expiration date: 2026-03-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.At about 8 months from primary, the surgeon planned to remove all components and implant an antibiotic spacer; however, the surgeon could not implant a spacer due to the presence of scar tissue and the tightness of the knee.The patient currently has no implants in.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 5+ R
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14753805
• Report Number: 3005180920-2022-00474
• Device Sequence Number: 5595555
• Product Code: JWH
• UDI-Device Identifier: 07630030862427
• UDI-Public: 07630030862427
• 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: 2021
• Device Explanted Year: 2022
• 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): 06/21/2022

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: 03/24/2026
• Device Model Number: 02.12.0025R
• Device Catalogue Number: 02.12.0025R
• Device Lot Number: 2101944
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male