MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERIKA FEMORAL COMPONENT SPHERIKA CEMENTED S3+L; KNEE FEMORAL COMPONENT

Catalog Number	02.12.KA13L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02-aug-2024.Lot 2346852: (b)(4) items manufactured and released on 16-apr-2024.Expiration date: 2029-04-02.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-spherika 02.12.E0313fl tibial insert fixed sphere flex size 3/13 mm l e-cross (k202022) lot 2238817: (b)(4) items manufactured and released on 02-nov-2022.Expiration date: 2027-10-17.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.Gmk-spherika 02.12.E002rp patella resurfacing size 2 e-cross (k202022) lot 2346255: (b)(4) items manufactured and released on 06-feb-2024.Expiration date: 2029-01-23.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.Gmk-spherika 02.07.1203l tibial tray fixed cemented size 3 l (k090988) lot 2345288: (b)(4) items manufactured and released on 20-mar-2024.Expiration date: 2029-03-07.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
At about 2 months after primary, the patient came in reporting instability and the cause is unknown.The surgeon revised all components to gmk-hinge components and the surgery was completed successfully.

• Brand Name: GMK-SPHERIKA FEMORAL COMPONENT SPHERIKA CEMENTED S3+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: 20046119
• Report Number: 3005180920-2024-00638
• Device Sequence Number: 7998432
• Product Code: JWH
• UDI-Device Identifier: 07630345716217
• UDI-Public: 07630345716217
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K211004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/23/2024

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 Catalogue Number: 02.12.KA13L
• Device Lot Number: 2346852
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2024
• 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 Age: 68 YR
• Patient Sex: Female