MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® BIOFOAM® TIBIA BASE W/O SCREWHOLES SIZE 4; KNEE COMPONENT

Model Number KTSLFM40

Device Problems Loose or Intermittent Connection (1371); Failure to Osseointegrate (1863); Loss of Osseointegration (2408)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This event will be updated when investigation is complete.

Event Description

Allegedly the left knee always had pain, failure to integrate aseptic loosening.Dr.(b)(6) removed the femur, tibia, poly and keel and patella was kept.

• Brand Name: ADVANCE® BIOFOAM® TIBIA BASE W/O SCREWHOLES SIZE 4
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 8922871
• MDR Text Key: 155268662
• Report Number: 3010536692-2019-01009
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: M684KTSLFM401
• UDI-Public: M684KTSLFM401
• Combination Product (y/n): N
• PMA/PMN Number: K063128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: KTSLFM40
• Device Catalogue Number: KTSLFM40
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/23/2019
• Date Manufacturer Received: 07/23/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR