MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L

Model Number 02.12.0210FL

Device Problems Failure to Align (2522); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 10/13/2020

Event Type  Injury  

Event Description

The patient came in reporting pain due to a misaligned patella bone(the patella was tilted).The cause of the misaligned is unknown.The surgeon performed a patellar lateral release and revised the gmk-sphere tibial insert - flex s2l - 10 mm with a gmk sphere cr tibial insert s2l 14mm.When the surgeon trailed for the liner, he didn't like the way it felt, so he decided to go up in size.

• Brand Name: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 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: 10822491
• MDR Text Key: 216311850
• Report Number: 3005180920-2020-00793
• Device Sequence Number: 1
• Product Code: KWH
• UDI-Device Identifier: 07630030826139
• UDI-Public: 07630030826139
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K121416
• 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: 11/11/2020

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 Expiration Date: 06/14/2023
• Device Model Number: 02.12.0210FL
• Device Catalogue Number: 02.12.0210FL
• Device Lot Number: 183002
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2018
• 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
• Patient Age: 60 YR