MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM; KNEE FIXED TIBIAL INSERT

Model Number	02.12.0412FL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting instability and the cause of the instability is unknown.At 1 year and 10 months after the primary, the surgeon revised the insert and patella.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 27 january 2022: lot 1906086: (b)(4) items manufactured and released on 09-ago-2019.Expiration date: 2024-07-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Additional implant involved: gmk-sphere 02.07.0035rp patella resurfacing site 3 (k090988) lot.1908306.Batch review performed on 27 january 2022: lot 1908306: (b)(4) items manufactured and released on 07-nov-2019.Expiration date: 2024-10-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM
• Common Device Name: KNEE FIXED TIBIAL INSERT
• 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: 13504469
• Report Number: 3005180920-2022-00095
• Device Sequence Number: 5354242
• Product Code: JWH
• UDI-Device Identifier: 07630030826573
• UDI-Public: 07630030826573
• 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: 2020
• 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): 02/10/2022

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: 07/24/2024
• Device Model Number: 02.12.0412FL
• Device Catalogue Number: 02.12.0412FL
• Device Lot Number: 1906086
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2019
• 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