MAUDE Adverse Event Report: PARAGON28, INC. APEX 3D TOTAL ANKLE REPLACEMENT SYSTEM; PROSTHESIS, ANKLE

Model Number	P10-310-I207-S
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Cellulitis (1768); Erythema (1840); Bone Fracture(s) (1870); Necrosis (1971); Pain (1994); Fluid Discharge (2686); Osteomyelitis (4533); Skin Infection (4544); Medical device site infection (4845); Wound Odor (4866)
Date of Event	08/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4), this is initial report.Images received were reviewed and clinical detected a small amount of subcutaneous gas in the anterior ankle wound.The dhr was reviewed.There were no nonconformances or temporary deviations associated with this failure on this lot.All characteristics inspected upon initial receipt were found conforming to specifications.There are no indications of manufacturing issues which would have contributed to this event.
Event or Problem Description
The patient presented osteomyelitis with cellulitis and ankle pain on the right ankle including redness and scabbing of incision.Revision surgery took place to remove the implant and the hospital discarded the implant.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a2, a5, b2, b5, b4, b5, b7, d2a, d4(udi), d5, d10, e1, e2, e3, g1, g3, g6, h2, h6, h10.D10: p10-100-br3l-s, tibia arc rt sz 3 lg 3dp strl, lot 260f3332312.P10-251-tlr2-s, talus flat rt sz 2 tps strl, lot 260f0082412.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was further reported that approximately 5 months post implantation of a right total ankle arthroplasty, the patient developed wound dehiscence, erythema, and drainage, and was admitted for osteomyelitis with secondary cellulitis, exposed tendon with odor, and pain.Patient underwent an i&d to bone and necrotic tissue, and completed a tendon transfer and wound closure.Intra-op cultures were positive for prevotella and the poly was exchanged without complication.Attempts have been made and all available information has been provided.

• Brand Name: APEX 3D TOTAL ANKLE REPLACEMENT SYSTEM
• Common Device Name: PROSTHESIS, ANKLE
• Manufacturer (Section D): PARAGON28, INC.; 14445 grasslands drive; 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: 23300686
• Report Number: 3008650117-2025-00004
• Device Sequence Number: 10037401
• Product Code: HSN
• UDI-Device Identifier: 00889795072238
• UDI-Public: (01)00889795072238(10)2608191203
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K192994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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 Model Number: P10-310-I207-S
• Device Catalogue Number: P10-310-I207-S
• Device Lot Number: 2608191203
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White