MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION®MP TIB SCREWLESS BFSIZE 6+ LEFT; KNEE COMPONENT

Model Number	ETPLB6PL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
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, broken tibia component.
Additional Manufacturer Narrative
The alleged complaint is confirmed.Visual review of a provided image of the implant, etplb6pl lot 1890817, reveals that this implant has fractured in half.This implant was implanted for approximately 15 months in the 56 yo male patient.This implant was not returned for investigation; however, images of the failure were provided to assist with the investigation.This lot was manufactured in 2021.Review of the design history record (dhr) for the subject manufacturing lot indicates that this implant was manufactured to specification.There is no trend for this implant and failure, however, there is a total of eleven incidents involving the fracture of evolution®mp biofoam screwless tibia implants that have occurred since 2020.Past investigations found that this implant failure was due to user error or was traced to an adverse event related to the patient's condition.Regarding this complaint, it cannot be determined what may have led to the implant failure without additional information.The microport knee systems package insert (150806-4) lists "fracture by trauma or excessive loading, particularly in the presence of poor bone stock" as a possible adverse effect of total knee arthroplasty.This package insert also states, "correct selection of the prosthesis is important.The potential for success in knee joint replacement is increased by selection of the proper size, shape, and design of the prosthesis.Knee joint prostheses require careful seating and adequate bone support." mpo will continue to monitor this issue though complaint tracking.Methods: analysis of data provided by user/third party (4112).Analysis of production records (3331).Trend analysis (4110).Results: fracture problem (3252).Conclusions: device met specification.Device was used for treatment.Cause not established (4315).
Event or Problem Description
Allegedly, broken tibia component.

• Brand Name: EVOLUTION®MP TIB SCREWLESS BFSIZE 6+ LEFT
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 20196546
• Report Number: 3010536692-2024-00435
• Device Sequence Number: 12673451
• Product Code: LZO
• UDI-Device Identifier: M684ETPLB6PL1
• UDI-Public: M684ETPLB6PL1
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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: Health Professional
• Device Model Number: ETPLB6PL
• Device Catalogue Number: ETPLB6PL
• Device Lot Number: 1890817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male