MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L; TIBIAL TRAY CEMENTED FIXED

Model Number 02.07.1204L

Device Problems Unstable (1667); Failure to Osseointegrate (1863)

Patient Problem Inadequate Osseointegration (2646)

Event Date 06/15/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on (b)(6) 2021: lot 1810458: (b)(4) items manufactured and released on 20-mar-2019.Expiration date: 2024-03-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Another device involved: batch review performed on (b)(6) 2021: gmk-sphere 02.12.0004l femoral component sphere cemented size 4 (k121416) l lot 187135: (b)(4) items manufactured and released on 15-nov-2018.Expiration date: 2023-11-04.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

Event Description

Revision surgery 2 years and 1 month after primary for tibial and femoral component loosening.The patient had knee instability due to this.The surgeon revised successfully all the devices.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L
• Type of Device: TIBIAL TRAY CEMENTED FIXED
• 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: 12135349
• MDR Text Key: 266210353
• Report Number: 3005180920-2021-00566
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030819902
• UDI-Public: 07630030819902
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2024
• Device Model Number: 02.07.1204L
• Device Catalogue Number: 02.07.1204L
• Device Lot Number: 1810458
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention