MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0003L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L; KNEE FEMORAL COMPONENT

Model Number	02.12.0003L
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23-may-2022.Lot 1910648: (b)(4) items manufactured and released on 17-mar-2020.Expiration date: 2025-03-08.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs director: one year after primary tka in a severely varus patient the patella dislocates and the medial collateral ligament develops instability.It is therefore necessary to replace the system with a higher-stability device.This adverse event is not related to a device deficiency, rather to progression of disease and patella problems.
Event or Problem Description
Patella luxation and medial ligament instability 8 months after the primary surgery.The femoral component was changed to a gmk revision sc with stem, distal 4mm augment and a sc inlay.

• Brand Name: GMK-SPHERE 02.12.0003L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L
• Common Device Name: KNEE FEMORAL COMPONENT
• 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: 14652250
• Report Number: 3005180920-2022-00442
• Device Sequence Number: 5693922
• Product Code: JWH
• UDI-Device Identifier: 07630030825811
• UDI-Public: 07630030825811
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 06/10/2022

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: 03/08/2025
• Device Model Number: 02.12.0003L
• Device Catalogue Number: 02.12.0003L
• Device Lot Number: 1910648
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 06/10/2022
• 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 Age: 53 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White