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

Model Number	ETPKN5SL
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem 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).
Additional Manufacturer Narrative
Updated initial reporter name and investigation codes.
Event or Problem 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
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11334901
• Report Number: 3010536692-2021-00078
• Device Sequence Number: 14480058
• Product Code: HRY
• UDI-Device Identifier: M684ETPKN5SL1
• UDI-Public: M684ETPKN5SL1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 04/30/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention