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

Model Number 02.07.1204L

Device Problems Material Rupture (1546); Appropriate Term/Code Not Available (3191)

Patient Problem Tissue Breakdown (2681)

Event Date 05/03/2021

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 14 may 2021: lot 1904222: (b)(4) items manufactured and released on 06-nov-2019.Expiration date: 2024-10-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Additional device involved: batch review performed on 14 may 2021: gmk-sphere 02.12.0411fl tibial insert fixed sphere flex size 4/11 mm l (k140826) lot 189007: (b)(4) items manufactured and released on 05-feb-2019.Expiration date: 2024-01-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.

Event Description

11 months after the primary, the patient came in reporting pain due to a ruptured patella tendon and the cause of the ruptured patella tendon is unknown.The surgeon repaired the patella tendon and revised tibial tray and insert.The surgery was completed successfully.

• Brand Name: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 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: 11900857
• MDR Text Key: 253457521
• Report Number: 3005180920-2021-00449
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/28/2021

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
• Device Operator: Health Professional
• Device Model Number: 02.07.1204L
• Device Catalogue Number: 02.07.1204L
• Device Lot Number: 1904222
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/28/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2019
• 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