MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK SPHERE TOTAL KNEE SYSTEM; KNEE TIBIAL INSERT

Model Number	02.12.0410FR
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs director: 4 years after primary tka the joint is losing stability and a thicker insert is needed.At the same time, the patella is resurfaced because some pain was felt at the femoro-patellar joint, formerly not treated.This should be categorized as disease progression, there is no reason to suspect a malfunctioning device.
Event or Problem Description
At about 3 years and 10 months after primary, the patient came in reporting instability and possible loosening of joint stability over time, with consequent patellofemoral pain.The surgeon revised successfully the liner (10mm) with a thicker one (13mm) and resurfaced patient's patella bone.

• Brand Name: GMK SPHERE TOTAL KNEE SYSTEM
• Common Device Name: KNEE TIBIAL INSERT
• 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: 20469755
• Report Number: 3005180920-2024-00827
• Device Sequence Number: 7472154
• Product Code: JWH
• UDI-Device Identifier: 07630030826542
• UDI-Public: 07630030826542
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2024

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 Model Number: 02.12.0410FR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White