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

Model Number 02.07.1205L

Device Problem Collapse (1099)

Patient Problem Pain (1994)

Event Date 05/04/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 31 may 2021: lot 162180: (b)(4) items manufactured and released on 30-may-2016.Expiration date: 2021-05-16.No anomalies found related to the problem.To date, all items of the same lot have been already sold.No other similar events have been reported on this lot since 2017.

Event Description

4 years 6 months after the primary the patient came in reporting pain due to a collapsed tibial tray and the cause is unknown.The surgeon revised the tibial tray and insert.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L
• Type of Device: KNEE TIBIAL TRAY
• 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: 11907349
• MDR Text Key: 253460927
• Report Number: 3005180920-2021-00462
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030819926
• UDI-Public: 07630030819926
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2021
• Device Model Number: 02.07.1205L
• Device Catalogue Number: 02.07.1205L
• Device Lot Number: 162180
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/30/2016
• 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