MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/20 MM R; KNEE TIBIAL INSERT FIXED

Model Number	02.12.0320FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 8 months after the primary knee surgery, the patient came in reporting instability.The surgeon revised femur and liner (20 to 26 mm) and decided to convert the patient to a semi-constrained construct.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 17 january 2023.Lot 2000440: (b)(4) items manufactured and released on 16-march-2020.Expiration date: 2025-03-02.No anomalies found related to the problem.To date, only the item involved in the complaint has been sold during the period of review.Additional component involved: gmk-sphere 02.12.0023r femoral component sphere cemented size 3+ r (k140826) lot 2112027: (b)(4) items manufactured and released on 14-dec-2021.Expiration date: 2026-11-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/20 MM R
• Common Device Name: KNEE TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16362565
• Report Number: 3005180920-2023-00041
• Device Sequence Number: 7258518
• Product Code: JWH
• UDI-Device Identifier: 07630030826504
• UDI-Public: 07630030826504
• 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: 2022
• Device Explanted Year: 2023
• 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): 02/13/2023

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: 03/02/2025
• Device Model Number: 02.12.0320FR
• Device Catalogue Number: 02.12.0320FR
• Device Lot Number: 2000440
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2020
• 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 Sex: Female