MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L; KNEE TIBIAL TRAY

Catalog Number	02.07.1205L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On the (b)(6) 2019, the patient underwent a medacta knee primary surgery.Presently, the patient came in reporting pain.The mri scan revealed the competitor cement (depuy high viscosity bone cement) deterioration.It is possible that, due to this event, the implants were no longer properly fixed to the bone.The patient has been revised with competitor implants on an unknown date.
Additional Manufacturer Narrative
Batch review performed on 07-dec-2023 lot 1811572: 154 items manufactured and released on 20-mar-2019.Expiration date: 2024-03-16.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported case during the period of review.Additional component involved: batch review performed on 07-dec-2023 gmk-sphere 02.12.0004l femoral component sphere cemented size 4 l (k121416) lot.154696: 76 items manufactured and released on 13-oct-2015.Expiration date: 2020-09-29.No anomalies found related to the problem.To date, 75 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 5 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: 18282988
• Report Number: 3005180920-2023-00970
• Device Sequence Number: 6264484
• Product Code: JWH
• UDI-Device Identifier: 07630030819926
• UDI-Public: 07630030819926
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 12/07/2023

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: 03/16/2024
• Device Catalogue Number: 02.07.1205L
• Device Lot Number: 1811572
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2019
• 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: Male