MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.12.E0210FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L E-CROSS; KNEE TIBIAL INSERT FIXED SPHERE FLEX

Catalog Number	02.12.E0210FL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26-jan-2024 lot 2116919: 30 items manufactured and released on 24-jan-2022.Expiration date: 2027-01-06.No anomalies found related to the problem.To date, 28 items of the same lot have been sold with no similar reported case during the period of review clinical evaluation performed by medical affairs director: 1.25 years after primary cemented tka, anterior knee pain is perceived by the patient and the patello-femoral joint is also reconstructed with artificial devices.As customary, during this operation the insert of the tibiofemoral prosthetic device is also replaced.The thickness of the insert was slightly increased to enhance joint stability: it is normal that after some time the collateral ligaments may stretch and therefore the opportunity of gaining some additional joint stability is welcome.No hints of malfunctioning devices.
Event or Problem Description
At about 1 year and 2 months after primary, the patient came in reporting anterior knee pain and patella bone resurfacing has been performed.During the revision, knee instability has been detected and for this reason the insert was revised (from 10mm to 12mm).Slight external rotation of the tibial lbaseplate has been observed, but it is unknown if this contributed to the instability.Because of the satisfaction of kinematic alignment of the knee with the higher liner and patella implant, no further implants were revised.

• Brand Name: GMK-SPHERE 02.12.E0210FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L E-CROSS
• Common Device Name: KNEE TIBIAL INSERT FIXED SPHERE FLEX
• 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: 18701847
• Report Number: 3005180920-2024-00043
• Device Sequence Number: 20372432
• Product Code: JWH
• UDI-Device Identifier: 07630971261273
• UDI-Public: 07630971261273
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K202022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 02/14/2024

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.E0210FL
• Device Lot Number: 2116919
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2022
• 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: 74 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White