MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 5 STANDARD 12MM LEFT; KNEE COMPONENT

Model Number	EIS5S12L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	08/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Sade 17k001 - patient # (b)(6).Allegedly, subject (b)(6) had a revision surgery at michigan medicine by dr.Hallstrom on (b)(6) 2022.The office note on (b)(6) 2022 states "work up for infection was negative.Implant may be loose.Due to her symptoms, worsening pain, and limited function, she is a candidate for revision of her knee replacement." per note, subject wanted to proceed with revision surgery.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.Review of the complaint, efsrp4pl lot: 1759652, eis5s12l, lot: 03010983331757543, etplb5sl lot: 1815560, etpk1556 lot: 1780844, does not reveal any evidence of failure involving these implants.These implants were not returned for investigation, nor were any pictures or other medical documentation provided to assist with the investigation.These implants were implanted for approximately 24 months in the 65 yo female patient before a revision surgery was required.The patient began to experience pain and limited function approximately 2 months prior to the revision surgery.The incident description suggests that the implants may be loose.While this is possible, mpo is unable to confirm this failure without additional information.The mpo knee systems package insert (150806-3) lists?) inadequate range of motion due to improper selection or positioning of components, periarticular calcification, flexion contracture? and? pain? as potential adverse effects.This package insert also states? 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? these implant lots were manufactured in 2018 (eis5s12l, efsrp4pl, etpk1556) and 2019 (etplb5sl).Review of the design history records (dhr) for the subject manufacturing lots indicate that these implants were manufactured to specification.There are no trends for any of these implants and failures.It cannot be concluded what the level of contribution, if any, that the product had to the complaint.No further evaluations can be made without return of the product or receipt of other clinical information.

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 5 STANDARD 12MM 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: 21242575
• Report Number: 3010536692-2025-00018
• Device Sequence Number: 17044417
• Product Code: HRY
• UDI-Device Identifier: M684EIS5S12L1
• UDI-Public: M684EIS5S12L1
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• 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): 12/09/2025

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: EIS5S12L
• Device Catalogue Number: EIS5S12L
• Device Lot Number: 03010983331757543
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 12/09/2025
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Weight: 84 KG