MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R; CEMENTED FEMORAL COMPONENT

Model Number	02.12.0024R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 january 2022.Lot 2003252: (b)(4) items manufactured and released on 20-jul-2020.Expiration date: 2025-jul-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Additional implant involved: gmk-sphere 02.12.T3i4r tibial tray fixed cemented size t3-i4 r (k121416) lot.2001625.Batch review performed on 20 january 2022.Lot 2001625: (b)(4) items manufactured and released on 07-jul-2020.Expiration date: 2025-jun-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Additional implant involved: gmk-sphere 02.12.0413crr tibial insert fixed sphere cr size 4/13 mm r (k181635) lot.1901355.Batch review performed on 20 january 2022.Lot 1901355: (b)(4) items manufactured and released on 21-may-2019.Expiration date: 2024-jun-08.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 1 similar reported event.Additional implant involved: gmk-sphere 02.07.0036rp patella resurfacing size 4 (k113571) lot.2006038.Batch review performed on 20 january 2022.Lot 2006038: (b)(4) items manufactured and released on 03-aug-2020.Expiration date: 2025-jul-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 1 similar reported event.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.At 1 year after the primary surgery, the surgeon performed a washout, removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ 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: 13468874
• Report Number: 3005180920-2022-00081
• Device Sequence Number: 4826810
• Product Code: JWH
• UDI-Device Identifier: 07630030862403
• UDI-Public: 07630030862403
• 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): 02/07/2022

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: 07/12/2025
• Device Model Number: 02.12.0024R
• Device Catalogue Number: 02.12.0024R
• Device Lot Number: 2003252
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2020
• 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