MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE 02.07.1202L TIBIAL TRAY FIXED CEMENTED SIZE 2 L

Model Number	02.07.1202L
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Metal Related Pathology (4530)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had suffered from pain for almost 1 year, presence of heavy metals.Revision surgery performed 11 months after the primary surgery due to nickel allergy and prosthetic loosening that had been detected after scintigraphic imaging.Tricompartmental prosthesis on a deformation greater than 10 degrees in the frontal plane.The revision went well.According to the surgeon, the loosening was caused by the allergy.
Additional Manufacturer Narrative
Batch review performed on 06 december 2021: lot 2004703: (b)(4) items manufactured and released on 10-sep-2020.Expiration date: 2025-aug-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event.Clinical evaluation performed by medical affairs director: 1 year after primary hybrid tka the patient is painful and the cementless femoral component is found loose.The patient has been found to have nickel allergy and this could well be the cause for the loosening.No reason to suspect a faulty device at the origin of this adverse event.

• Brand Name: GMK-SPHERE 02.07.1202L TIBIAL TRAY FIXED CEMENTED SIZE 2 L
• Common Device Name: TIBIAL TRAY FIXED CEMENTED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13010046
• Report Number: 3005180920-2021-00968
• Device Sequence Number: 13884947
• Product Code: JWH
• UDI-Device Identifier: 07630030819865
• UDI-Public: 07630030819865
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 12/15/2021

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: 08/31/2025
• Device Model Number: 02.07.1202L
• Device Catalogue Number: 02.07.1202L
• Device Lot Number: 2004703
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/10/2020
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White