MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0312FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM L; TIBIAL INSERT FIXED FLEX

Model Number	02.12.0312FL
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2021: lot 2010591: (b)(4) items manufactured and released on 14-dec-2020.Expiration date: 2025-11-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.Other devices involved: batch review performed on (b)(6) 2021: lot 2005743: (b)(4) items manufactured and released on 3-sep-2020.Expiration date: 2025-08-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event (knee instability).
Event or Problem Description
On (b)(6) 2021, at 3 weeks after the primary surgery, the patient came in due to signs of an infection.The surgeon performed a washout and revised the poly and the surgery was completed successfully.Subsequently, on (b)(6) 2021, the patient had another liner revision due to infection and instability.The liner was upsized successfully.In both cases the pathogen is unknown.
Event or Problem Description
On (b)(6) 2021, at 3 weeks after the primary surgery, the patient came in due to signs of an infection.The surgeon performed a washout and revised the poly and the surgery was completed successfully.The surgeon implanted thicked liner due to the patient had some instability too.Subsequently, on (b)(6) 2021, the patient had another liner revision due to infection and instability.The liner was upsized successfully.In both cases the pathogen is unknown.

• Brand Name: GMK-SPHERE 02.12.0312FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM L
• Common Device Name: TIBIAL INSERT FIXED FLEX
• 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: 12720053
• Report Number: 3005180920-2021-00835
• Device Sequence Number: 11103448
• Product Code: JWH
• UDI-Device Identifier: 07630030826375
• UDI-Public: 07630030826375
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2021

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: 11/29/2025
• Device Model Number: 02.12.0312FL
• Device Catalogue Number: 02.12.0312FL
• Device Lot Number: 2010591
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 11/26/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2020
• 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; Other
• Patient Sex: Female