MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® REV TIB MOD KEEL; KNEE COMPONENT

Model Number	ETRKMK36
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Unspecified Infection (1930); Osteolysis (2377)
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, patient was revised due to aseptic loosening tibia|infection|lysis tibia.Srnjr number: 5118495.Side: r.Gender: f.
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.Mpo was made aware of this revision from the united kingdom national joint registry.The available details alleges that this female patient was revised approximately 36 months after the primary operation due to alleged infection, lysis of the tibia, and loosening of the tibia.The revised implants have not been returned to mpo, nor have any medical records, operative notes, radiographs, or other clinically relevant information been received to confirm the alleged complications.Review of the device history record (dhr) for the subject manufacturing lots indicates that these products met all established acceptance criteria throughout manufacturing processes, including all aspects related to cleaning and sterility.Furthermore, no other complaint reports have been received for the subject manufacturing lots.Mpo is unable to evaluate the indications of tibial lysis and tibial implant loosening from the available information.Infection is a known risk of total knee arthroplasty and can influence implant fixation.However, mpo is unable to determine the source of infection or its possible contribution to the other described complications.Per the mpo knee systems package insert, 150806, "the patient must be advised of the limitations of the reconstruction and the need for protection of the prosthesis from full weight bearing until adequate fixation and healing have occurred.Excessive activity and trauma affecting the joint replacement have been implicated with failure of the reconstruction by loosening, fracture and/or wear of the prosthetic components.Loosening of the components can result in increased production of wear particles, as well as damage to the bone, making successful revision surgery more difficult.Periodic, long-term follow-up is recommended to monitor the position and state of the prosthetic components, as well as the condition of the adjoining bone.Periodic postoperative x-rays are recommended for close comparison with early post-op conditions to detect long term evidence of changes in position, loosening, bending, or cracking of components." this package insert also includes the alleged complications as possible adverse effects of total knee arthroplasty.At the time of this complaint, mpo identified trends for infection involving the design families of evolution tibial bases, evolution femoral implants, and evolution keels, screws, and accessories.These trends were the result of spikes in complaints from registry and literature sources.Mpo confirmed that the implant was not determined to be the source of infection in any case.To address trends for infection, mpo has updated the relevant dfmeas to document a risk index increase during 2025.Wd011598 for evolution femorals was updated to revision 16, and wd011632 for evolution tibial bases was updated to revision 18.There was not an impact to the risk index for wd012000 for evolution keels, screws, and accessories; therefore, an update was not required.Therefore, mpo has addressed the trends through these updates, and no other actions are deemed necessary based on investigation findings.Methods: device not returned (4114).Analysis of production records (3331).Trend analysis (4110).Results: no findings available (3221).Conclusions: device met specification.Device was used for treatment.Cause not established (4315).Adverse event related to patient condition (50).Known inherent risk of device (22).Correct type of reportable event: serious injury.

• Brand Name: EVOLUTION® REV TIB MOD KEEL
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline road; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 19637636
• Report Number: 3010536692-2024-00386
• Device Sequence Number: 7137754
• Product Code: JWH
• UDI-Device Identifier: M684ETRKMK361
• UDI-Public: M684ETRKMK361
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: Other
• Device Model Number: ETRKMK36
• Device Catalogue Number: ETRKMK36
• Device Lot Number: 1826379
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 10/30/2025; 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 Sex: Female