MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTIONMP TIB KEELED NONPOR SIZE 5 STANDARD LEF; KNEE COMPONENT

Model Number ETPKN5SL

Device Problem Loss of Osseointegration (2408)

Patient Problem Unspecified Infection (1930)

Event Date 12/06/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, when the insert was removed during the tka revision operation, there were clear signs of lipid absorption and participation in the removed insert, causing delamination and pitting.Physician's findings: since this is an early phenomenon within 2 years after surgery, there are concerns about product problems and long-term clinical results.Additional information received on 01/22/2021: allegedly, the patient was revised due to loosening of both the femur and tibial components as well as infection.Additional information received on 01/24/2021: primary operation date is (b)(6) 2018.Additional information received on 01/27/2021: product id's and lot numbers for tibial and femur revised components were obtained.(b)(4).

Manufacturer Narrative

Updated initial reporter name and investigation codes.

Event Description

Allegedly, when the insert was removed during the tka revision operation, there were clear signs of lipid absorption and participation in the removed insert, causing delamination and pitting.Physician's findings: since this is an early phenomenon within 2 years after surgery, there are concerns about product problems and long-term clinical results.Additional information received on 01/22/2021: allegedly, the patient was revised due to loosening of both the femur and tibial components as well as infection.Additional information received on 01/24/2021: primary operation date is mar 13,2018.Additional information received on 01/27/2021: product id's and lot numbers for tibial and femur revised components were obtained.Additional information received on 04/29/2021: revision facility and surgeon confirmation.Japan-oc-000000099.

• Brand Name: EVOLUTIONMP TIB KEELED NONPOR SIZE 5 STANDARD LEF
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11334901
• MDR Text Key: 232094615
• Report Number: 3010536692-2021-00078
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684ETPKN5SL1
• UDI-Public: M684ETPKN5SL1
• Combination Product (y/n): N
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: ETPKN5SL
• Device Catalogue Number: ETPKN5SL
• Device Lot Number: 1722533
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/27/2021
• Date Manufacturer Received: 01/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention