MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #5/10 MM L

Model Number 02.12.0510FL

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 13 november 2020.Lot 154120: 25 items manufactured and released on 14-dec-2015.Expiration date: 2020-11-23.No anomalies found related to the problem.To date, 23 items of the same lot have been already sold without any similar reported event.

Event Description

During the standard follow-up check, the surgeon dr.Freithofnig saw the tibial insert fixation screw highly unscrewed on the performed x-ray pictures.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX #5/10 MM L
• Type of Device: TIBIAL INSERT 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: 10940623
• MDR Text Key: 220156902
• Report Number: 3005180920-2020-00851
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 07630030826733
• UDI-Public: 07630030826733
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K121416
• 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: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2020
• Device Model Number: 02.12.0510FL
• Device Catalogue Number: 02.12.0510FL
• Device Lot Number: 154120
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/14/2015
• 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): Other
• Patient Age: 66 YR