MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L

Catalog Number	02.07.1203L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 10 months after primary, the patient came in reporting instability and the cause is unknown.The surgeon revised all components to revision components and the surgery completed successfully.
Additional Manufacturer Narrative
Batch review performed on 28-dec-2023, lot 2210918: 24 items manufactured and released on 21-sep-2022.Expiration date: 2027-09-07.No anomalies found related to the problem.To date, 23 items of the same lot have been sold with no similar reported case during the period of review.Additional implants involved in the event, batch review performed on 28-dec-2023.Gmk-sphere 02.12.0023l femoral component sphere cemented size 3+ l (k140826) lot.2215962.Lot 2215962: 36 items manufactured and released on 19-oct-2022.Expiration date: 2027-10-09.No anomalies found related to the problem.To date, 32 items of the same lot have been sold with no similar reported case during the period of review.Gmk-sphere 02.12.0314fl tibial insert fixed sphere flex #3/14 mm l (k121416) lot.187216, lot 187216: 30 items manufactured and released on 03-jan-19.Expiration date: 2023-12-11.No anomalies found related to the problem.To date, 19 items of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L
• Common Device Name: 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: 18510520
• Report Number: 3005180920-2023-01106
• Device Sequence Number: 20579204
• Product Code: JWH
• UDI-Device Identifier: 07630030819889
• UDI-Public: 07630030819889
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2024

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: 02.07.1203L
• Device Lot Number: 2210918
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2022
• 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