MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L; KNEE CEMENTED FEMUR

Model Number	02.12.0005L
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain due to loose implants and the cause is unknown.The surgeon revised all components with revision components 2 years and 1 month after primary.The surgery was completed successfully.There was no cement adhered to the implants.The cause of this is unknown.
Additional Manufacturer Narrative
Batch review performed on 04 april 2022: lot 181852: (b)(4) items manufactured and released on 26-jun-2018.Expiration date: 2023-06-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional devices involved : batch review performed on 04 april 2022: gmk-sphere 02.07.1204l tibial tray fixed cemented size 4 l (k090988) lot 1900509: (b)(4) items manufactured and released on 21-may-2019.Expiration date: 2024-05-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

• Brand Name: GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L
• Common Device Name: KNEE CEMENTED FEMUR
• 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: 14191915
• Report Number: 3005180920-2022-00306
• Device Sequence Number: 11856859
• Product Code: JWH
• UDI-Device Identifier: 07630030825859
• UDI-Public: 07630030825859
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2022

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: 06/12/2023
• Device Model Number: 02.12.0005L
• Device Catalogue Number: 02.12.0005L
• Device Lot Number: 181852
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2018
• 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