MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L; KNEE TIBIAL TRAY

Model Number	02.12.T3I4L
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 june 2023: lot 1909442: (b)(4) items manufactured and released on 23-march-2020.Expiration date: 2025-03-10.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.Clinical evaluation performed by medacta medical affairs director: 3 years and 9 monhts after primary cemented tka the patient feels discomfort and the surgeon deems that the tibial component is loose, so he proceeds to replacement to a constrained device.The report mentions that both the tibial and femoral components were free of cement at removal: this may indicate a problem during cementation at primary surgery, but we have no means to determine what may have happened.There is no reason, from the information received in the report, to suspect a defective device at the origin of this loosening: aseptic loosening is a possible adverse event following tka, described in literature and mentioned in the instructions for use of the device.
Event or Problem Description
At about 3 years 9 months after primary, revision surgery performed for cemented tibial tray loosening.No cement attachment observable on the components.The surgeon revised successfully the system to gmk hinge sensitin and resurfaced the patient's patella bone.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L
• Common Device Name: KNEE TIBIAL TRAY
• 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: 17256766
• Report Number: 3005180920-2023-00481
• Device Sequence Number: 6058705
• Product Code: JWH
• UDI-Device Identifier: 07630030827136
• UDI-Public: 07630030827136
• 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: 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): 07/04/2023

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: 03/10/2025
• Device Model Number: 02.12.T3I4L
• Device Catalogue Number: 02.12.T3I4L
• Device Lot Number: 1909442
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2020
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White