MAUDE Adverse Event Report:; INSERT, 3D EX SZ 4LT 11MM

Catalog Number 391-11-704

Device Problem Unstable (1667)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Corrected data: original initial report was submitted as follow up in error.

Event Description

Revision surgery - due to the patient's knee being loose and unstable, surgeon went and replaced it with a ps femur.

• Type of Device: INSERT, 3D EX SZ 4LT 11MM
• MDR Report Key: 10686953
• MDR Text Key: 211639324
• Report Number: 1644408-2016-00463
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/08/2020

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: No Information
• Device Catalogue Number: 391-11-704
• Device Lot Number: 59604255
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention