MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.0411FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L; KNEE TIBIAL INSERT FIXED

Catalog Number	02.12.0411FL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 months after primary, the patient came in reporting instability due to laxity.The surgeon revised the insert with a thicker one (from 11mm to 13mm) and resurfaced the native patella.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 22-dec-2023.Lot 2302931: 75 items manufactured and released on 28-mar-2023.Expiration date: 2028-03-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of the review.

• Brand Name: GMK-SPHERE 02.12.0411FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L
• 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18526032
• Report Number: 3005180920-2023-01080
• Device Sequence Number: 6412144
• Product Code: JWH
• UDI-Device Identifier: 07630040728058
• UDI-Public: 07630040728058
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K140826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 01/17/2024

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 Catalogue Number: 02.12.0411FL
• Device Lot Number: 2302931
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2023
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Race: White