MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. INSERT

Device Problems Naturally Worn (2988); Insufficient Information (3190)

Patient Problems Reaction (2414); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, patient was revised due to insert exchange.Additional information: left knee.

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Manufacturer Narrative

See attached - attachment: [mommemo.Pdf].

Manufacturer Narrative

Additional information obtained confirmed the patient underwent a poly exchange due to insert wear.

• Brand Name: INSERT
• Type of Device: INSERT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9644406
• MDR Text Key: 176947000
• Report Number: 3010536692-2020-00082
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/09/2020
• Date Manufacturer Received: 01/09/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR