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

Catalog Number	02.12.T3I4L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed due to pain performed about 1 year and 2 months after the primary surgery.During the revision, it was noted that the cement had not adhered to the femoral and tibial components (cement was not medacta).All components revised to gmk revision system.
Additional Manufacturer Narrative
Batch review performed on 6 may 2024.Lot 2204684: (b)(4) items manufactured and released on 12-jul-2022.Expiration date: 2027-jun-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department one year after primary cemented tka, at revision surgery, it is found that the cement did not adhere to the metal implants.This can be due to a number of different factors: the most influential ones are timing of application of the cement to the components and possible traces os moisture on the metal surfaces, but other factors may also play a role, such as room temperature, or storage temperature of the cement.There is no reason to suspect a defective device at the origin of this problem.Additional implants revised.Batch review performed on 6 may 2024 on gmk-sphere 02.12.0024l femoral component sphere cemented size 4+ l (k140826) lot.2211881 lot 2211881: (b)(4) items manufactured and released on 20-sep-2022.Expiration date: 2027-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 during the period of review.Batch review performed on 6 may 2024 on gmk-sphere 02.12.0410fl tibial insert fixed sphere flex size 4/10 mm l (k121416) lot.2112454.Lot 2112454: (b)(4) items manufactured and released on 11-oct-2021.Expiration date: 2026-sep-26.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L
• Common Device Name: KNEE CEMENTED 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: 19381857
• Report Number: 3005180920-2024-00347
• Device Sequence Number: 14384455
• Product Code: JWH
• UDI-Device Identifier: 07630030827136
• UDI-Public: 07630030827136
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K121416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/23/2024

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.T3I4L
• Device Lot Number: 2204684
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2022
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White