MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. REPIPHYSIS STEM; KNEE COMPONENT

Model Number CPEFDXXX

Device Problem Loss of Osseointegration (2408)

Patient Problem No Information (3190)

Event Date 09/15/2020

Event Type  Injury  

Event Description

Allegedly, the patient originally had a repiphysis distal femur system and was converted to a guardian distal femur system through a revision surgery.During this surgery, the original repiphysis stem was left to go along with the new guardian distal femur system (in 2007).Now, the repiphysis stem has loosened postoperatively, and the surgeon decided to revise all distal femur components in the revision.

Manufacturer Narrative

Please void all reports for medwatch no.: 3010536692-2020-00765.This report was mistakenly submitted due to user error.All reports pertaining to medwatch.No.3010536692-2020-00765 should be voided.

• Brand Name: REPIPHYSIS STEM
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11004352
• MDR Text Key: 221476200
• Report Number: 3010536692-2020-00765
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: CPEFDXXX
• Device Catalogue Number: CPEFDXXX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization