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

Catalog Number	02.12.0024L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery for infection at about 3 years and 3 months from primary.The surgeon performed a washout, removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.The pathogen is unknown.
Additional Manufacturer Narrative
Batch review performed on 26 october 2023: lot 1910627: (b)(4) items manufactured and released on 17-mar-2020.Expiration date: 2025-03-06.No anomalies found related to the problem.To date, all the items of the same lot have been sold without any similar reported event in the period of review.Other implants involved, batch review performed on 26 october 2023: gmk-sphere 02.12.0410fl tibial insert fixed sphere flex size 4/10 mm l (k121416) lot 1908768: (b)(4) items manufactured and released on 07-nov-2019.Expiration date: 2024-10-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Gmk-sphere 02.12.T3i4l tibial tray fixed cemented size t3-i4 l (k121416) lot 1907948: (b)(4) items manufactured and released on 03-mar-2020.Expiration date: 2025-02-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.Gmk-sphere 02.07.0035rp patella resurfacing size 3 (k090988) lot 1910556: (b)(4) items manufactured and released on 03-feb-2020.Expiration date: 2025-01-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.
Additional Manufacturer Narrative
On the 2 december 2023 we were informed that the antibiotic spacer was removed on the (b)(6) 2023 and permanent implants were put in.The surgery was completed successfully.
Event or Problem Description
Revision surgery for infection at about 3 years and 3 months from primary.The surgeon performed a washout, removed all implants and implanted an antibiotic spacer.The surgery was completed successfully.The pathogen is unknown.On the 2 december 2023 we were informed that the antibiotic spacer was removed on the (b)(6) 2023 and permanent implants were put in.The surgery was completed successfully.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18099117
• Report Number: 3005180920-2023-00890
• Device Sequence Number: 18059990
• Product Code: JWH
• UDI-Device Identifier: 07630030862397
• UDI-Public: 07630030862397
• 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: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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: 03/06/2025
• Device Catalogue Number: 02.12.0024L
• Device Lot Number: 1910627
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2020
• 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: Female