MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L; KNEE CEMENTED FEMORAL COMPONENT

Model Number	02.12.0003L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year 8 months after the primary, the patient came in reporting pain due to a ruptured mcl that was caused from twisting the knee when entering a car.The surgeon revised all components to hinge components and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 13 march 2023 lot 2012726: (b)(4) manufactured and released on 01-feb-2021.Expiration date: 2026-01-20.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.Additional involved implants: batch review performed on 13 march 2023 on gmk-sphere 02.12.0310fl tibial insert fixed sphere flex size 3/10 mm l (k121416) lot.2010587.Lot 2010587: (b)(4) manufactured and released on 26-nov-2020.Expiration date: 2025-10-29.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with another similar reported event during the period of review.Batch review performed on 13 march 2023 on gmk-sphere 02.12.T4i3l tibial tray fixed cemented size t4-i3 l (k121416) lot.2008718.Lot 2008718: (b)(4) manufactured and released on 19-01-2021.Expiration date: 2025-12-29.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L
• Common Device Name: KNEE CEMENTED 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16563757
• Report Number: 3005180920-2023-00164
• Device Sequence Number: 5560787
• Product Code: JWH
• UDI-Device Identifier: 07630030825811
• UDI-Public: 07630030825811
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2023
• 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): 03/17/2023

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: 01/20/2026
• Device Model Number: 02.12.0003L
• Device Catalogue Number: 02.12.0003L
• Device Lot Number: 2012726
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2021
• 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: Female