MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0006L FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 L; KNEE FEMORAL COMPONENT

Catalog Number	02.12.0006L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 may 2024 lot 2003199: (b)(4) items manufactured and released on 30-jul-2020.Expiration date: 2025-07-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Other devices involved: gmk-sphere 02.07.1205l tibial tray fixed cemented size 5 l (k090988) lot 2005566: (b)(4) items manufactured and released on 09-oct-2020.Expiration date: 2025-09-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Gmk-sphere 02.12.0510fl tibial insert fixed sphere flex size 5/10 mm l (k121416) lot 2005765: (b)(4) items manufactured and released on 11-aug-2020.Expiration date: 2025-07-29.No anomalies found related to the problem.To date, all the items of the same lot have been sold with another similar reported event during the period of review.Gmk-sphere 02.07.0034rp patella resurfacing size 2 (k090988) lot 2101550: (b)(4) items manufactured and released on 08-apr-2021.Expiration date: 2026-03-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
Knee revision surgery at abot 2 years and 8 months post primary due to infection.All devices revised successfully.

• Brand Name: GMK-SPHERE 02.12.0006L FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 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: 19389771
• Report Number: 3005180920-2024-00343
• Device Sequence Number: 6955600
• Product Code: JWH
• UDI-Device Identifier: 07630030825873
• UDI-Public: 07630030825873
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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: 07/20/2025
• Device Catalogue Number: 02.12.0006L
• Device Lot Number: 2003199
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2020
• 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: Unknown