MAUDE Adverse Event Report: PARAGON 28 APEX 3D X-LINK VTMN E POLY 2X10MM NEU STRL; PROSTHESIS, KNEE

Catalog Number	P10-310-I210-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Osteopenia/ Osteoporosis (2651); Swelling/ Edema (4577); Joint Impingement (4834); Exostosis (bone) (4891)
Date of Event	04/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 17 months post implantation of a right total ankle arthroplasty, the patient presented with pain and swelling and underwent a revision where significant scar tissue was resected from the anterior joint, significant osteophytes were debrided from the medial and lateral gutters, and the poly was exchanged.A competitor screw was placed to help support the medial malleolus.During the revision, it was noted that the tibial and talar components were well-fixed.Upon examination of the intraoperative x-rays, it was noted that the stress reaction of the medial tibia was substantial compared to preoperative x-rays, and it was believed that the medial portion of the talus and the medial portion of the tibia had significant impingement and this was causing stress change of the distal tibia.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: p10-251-tlr2-s, talus flat rt sz 2 tps strl, lot: 260f3002303.P10-101-br3s-s, tibia flat rt sz 3 std 3dp strl, lot: 260f14923a16.The customer has indicated that the device will not be returned for investigation as the location of the device is unknown.The investigation is in process and a final report will be submitted upon results.

• Brand Name: APEX 3D X-LINK VTMN E POLY 2X10MM NEU STRL
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): PARAGON 28; 14445 grasslands dr.; englewood CO 80112
• Manufacturer (Section G): PARAGON 28; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 25548241
• Report Number: 3008650117-2026-00312
• Device Sequence Number: 10762815
• Product Code: HSN
• UDI-Device Identifier: 00889795072269
• UDI-Public: (01)00889795072269(17)251120(10)260832520A02
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K192994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2026

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: Lay User/Patient
• Device Expiration Date: 11/20/2025
• Device Catalogue Number: P10-310-I210-S
• Device Lot Number: 260832520A02
• 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: 06/10/2026
• Initial Report FDA Received Date: 06/18/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White