MAUDE Adverse Event Report: EVOLUTION® CEMENTED STEM EXT17MM X 25MM; HIP COMPONENT

Model Number	ESC17025
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient underwent l tkr on (b)(6) 2022.Revised on (b)(6) 2025.The cause for revision was stability issues, large patient high bmi ligament laxity.(b)(4).
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Additional Manufacturer Narrative
This 61-year-old female patient underwent a revision operation approximately 37 months after the index operation due to alleged stability issues.All implants were removed and replaced with a revision system consisting of stems and augments on both the femoral and tibial sides.It was reported that the patient was of elevated bmi and experienced ligament laxity.The explanted devices were not returned for investigation, and mpo did not receive any radiographs, images, or operative notes for evaluation.Review of the device history record (dhr) for the subject manufacturing lots indicates that these products met all established acceptance criteria.Furthermore, review of historical complaint data does not reveal any similar complaint reports for the subject manufacturing lots.Based on the available information, it is most likely that the elevated bmi of the patient and noted ligament laxity could have led to increased instability since the index operation.The microport knee systems package insert (150806-4) notes the following as a possible adverse effect of total knee arthroplasty: "dislocation, migration and/or subluxation of prosthetic components from improper positioning, trauma, loss of fixation and/or muscle and fibrous tissue laxity." 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." there were not any trends for instability identified at the time of this complaint.This issue will continue to be monitored through complaint tracking.

• Brand Name: EVOLUTION® CEMENTED STEM EXT17MM X 25MM
• Common Device Name: HIP COMPONENT
• Manufacturer Contact: 5677 airline rd; arlington 38002 ; 9018674771
• MDR Report Key: 23609761
• Report Number: 3010536692-2025-00369
• Device Sequence Number: 15754031
• Product Code: JWH
• UDI-Device Identifier: M684ESC170251
• UDI-Public: M684ESC170251
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/06/2026

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: ESC17025
• Device Catalogue Number: ESC17025
• Device Lot Number: 1930786
• 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
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown