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

Model Number	02.12.0005R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 november 2021: lot 2010168: (b)(4) items manufactured and released on 21-jan-2021.Expiration date: 2026-01-11.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.Additional devices involved.Batch reviews performed on 02 november 2021: gmk-sphere 02.07.1205r tibial tray fixed cemented size 5 r (k090988) lot 2102521: (b)(4) items manufactured and released on 17-may-2021.Expiration date: 2026-05-03.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.Gmk-sphere 02.12.0511fr tibial insert fixed sphere flex size 5/11 mm r (k140826) lot 2005770: (b)(4) items manufactured and released on 03-sep-2020.Expiration date: 2025-08-23.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.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all implants and implanted an antibiotic spacer 1 month after primary.The surgery was completed successfully.
Additional Manufacturer Narrative
On (b)(6) 2022 it was noticed that there was an error in the batch review of the insert which was reported in the initial report.Here below you can find the corrected batch review.Gmk-sphere 02.12.0511fr tibial insert fixed sphere flex size 5/11 mm r (k140826) lot 2005770 batch review performed on (b)(6) 2021: lot 2005770: (b)(4) items manufactured and released on 03-sep-2020.Expiration date: 2025-08-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R
• Common Device Name: KNEE CEMENTED FEMUR
• 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: 12852078
• Report Number: 3005180920-2021-00919
• Device Sequence Number: 14532364
• Product Code: JWH
• UDI-Device Identifier: 07630030825866
• UDI-Public: 07630030825866
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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: 01/11/2026
• Device Model Number: 02.12.0005R
• Device Catalogue Number: 02.12.0005R
• Device Lot Number: 2010168
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2021
• 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: Unknown