MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION®MP TIB SCREWLESS BF SIZE 6 STANDARD LEF; KNEE COMPONENT

Model Number ETPLB6SL

Device Problems Break (1069); Loss of Osseointegration (2408)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, revised for broken loose tibia and femur easily removed.

Manufacturer Narrative

Additional information received on 6/3/2022.Patient had two traumatic events(injured from riding a scooter and then stepped in a pothole) which led to the revision surgery.Therefore, this manufacturer report number (b)(4) is considered no longer reportable since the adverse event was caused by the traumatic events and there's no alleged deficiency against the devices.Please void this report.

• Brand Name: EVOLUTION®MP TIB SCREWLESS BF SIZE 6 STANDARD LEF
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 12738746
• MDR Text Key: 279774581
• Report Number: 3010536692-2021-00556
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: M684ETPLB6SL1
• UDI-Public: M684ETPLB6SL1
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2022

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: Other
• Device Model Number: ETPLB6SL
• Device Catalogue Number: ETPLB6SL
• Device Lot Number: 1722143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/21/2021
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 10/21/2021; 10/21/2021
• Supplement Dates FDA Received: 02/23/2022; 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 61 KG