MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GUARDIAN® CEMENTED STEM LG COLLAR 152MM X 13MM; KNEE COMPONENT

Model Number 2500CC13

Device Problems Loose or Intermittent Connection (1371); Loss of Osseointegration (2408)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This event will be updated when investigation is complete.

Event Description

Allegedly, patient underwent a revision surgery due to the segmental stem loosening.

Manufacturer Narrative

Update problem and evaluation codes.

• Brand Name: GUARDIAN® CEMENTED STEM LG COLLAR 152MM X 13MM
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9256314
• MDR Text Key: 164443384
• Report Number: 3010536692-2019-01128
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: M6842500CC131
• UDI-Public: M6842500CC131
• Combination Product (y/n): N
• PMA/PMN Number: K013035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 2500CC13
• Device Catalogue Number: 2500CC13
• Device Lot Number: 03010658271719815
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/01/2019
• Date Manufacturer Received: 10/01/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR