MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.07.2803L TIBIAL TRAY FIXED CEMENTED SIZE 3 L TINBN COATED; KNEE TIBIAL TRAY FIXED CEMENTED

Model Number	02.07.2803L
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31-mar-2023 lot 2118543: (b)(4) items manufactured and released on 15-jun-2022.Expiration date: 2027-06-01.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 review.Clinical evaluation performed by medical affairs director: few weeks after primary cemented tka in a 70 year old lady, the tibial component subsides and needs replacement.The causes for this very early failure can be poor bone quality or insufficient cortical coverage on the tibial resection.From the images supplied, we are more inclined to think that the bone gave way.No reason to suspect a faulty device.
Event or Problem Description
Revision surgery performed at about 1 month and 2 weeks after primary due to cemented tibial tray subsidence.The surgeon revised successfully the femoral and tibial component and the insert.

• Brand Name: GMK-SPHERE 02.07.2803L TIBIAL TRAY FIXED CEMENTED SIZE 3 L TINBN COATED
• Common Device Name: KNEE TIBIAL TRAY FIXED CEMENTED
• 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: 16655171
• Report Number: 3005180920-2023-00201
• Device Sequence Number: 20458257
• Product Code: JWH
• UDI-Device Identifier: 07630030821806
• UDI-Public: 07630030821806
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K202684
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2023

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 Model Number: 02.07.2803L
• Device Catalogue Number: 02.07.2803L
• Device Lot Number: 2118543
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2022
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 85 KG