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

Model Number	02.12.0003L
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
At 18 days after the primary surgery, the patient came in reporting instability and the cause of the instability is unknown.The surgeon revised the femoral component and insert successfully.After the primary surgery, the patient has vascular surgery on the implanted leg and became very unstable.
Additional Manufacturer Narrative
Batch review performed on 04.11.2021; lot 2011998: (b)(4) items manufactured and released on 15-jan-2021.Expiration date: 2025-12-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without similar reported event.Other devices involved: gmk-sphere 02.12.0311fl tibial insert fixed sphere flex size 3/11 mm l (k140826) lot 2012698: (b)(4) items manufactured and released on 26-feb-2021.Expiration date: 2026-02-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without similar reported event.

• Brand Name: GMK-SPHERE 02.12.0003L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L
• Common Device Name: 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: 12874307
• Report Number: 3005180920-2021-00910
• Device Sequence Number: 4353350
• Product Code: JWH
• UDI-Device Identifier: 07630030825811
• UDI-Public: 07630030825811
• 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: 2021
• Device Explanted Year: 2021
• 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): 11/25/2021

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: 12/27/2025
• Device Model Number: 02.12.0003L
• Device Catalogue Number: 02.12.0003L
• Device Lot Number: 2011998
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2021
• 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: Other
• Patient Sex: Male