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

Model Number ETPLB6SL

Device Problem Loss of Osseointegration (2408)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, 7 months post op had increased weight bearing pain.44 months post op- no complaint just visit to doctor but can see some loosening.On (b)(6) 2022 patient was in pain, hyperflex occurred in show due to other issues components have not been revised.This was a prophecy case (b)(4).

Manufacturer Narrative

Additional information received on 6/29/2022.This manufacturer report number (b)(4) is considered no longer reportable since the adverse event was caused by a traumatic event(accident with a scooter that led to a bent/broken tibia base).The incident is related to trauma and not related to a device failure.Please void this report.

• Brand Name: EVOLUTION®MP TIB SCREWLESS BF SIZE 6 STANDARD LEFT
• 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: 14749850
• MDR Text Key: 294938184
• Report Number: 3010536692-2022-00225
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• 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: 1736864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/03/2022
• Date Manufacturer Received: 06/03/2022
• 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: 58 YR
• Patient Sex: Male