MAUDE Adverse Event Report: PARAGON 28 TIBIA ARC RT SZ 5 LG 3DP STRL; PROSTHESIS, ANKLE

Catalog Number	P10-100-BR5L-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Limb Fracture (4518); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	02/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 3 months post implantation of a right ankle prosthesis, the patient presented with pain and swelling and was diagnosed with a right medial malleolar stress fracture.Patient was treated with a cam boot and noted to be recovering.No other intervention has been reported.Attempts have been made and all information has been provided.
Additional Manufacturer Narrative
(b)(4).The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: TIBIA ARC RT SZ 5 LG 3DP STRL
• Common Device Name: PROSTHESIS, ANKLE
• 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: 24688143
• Report Number: 3008650117-2026-00078
• Device Sequence Number: 18645591
• Product Code: HSN
• UDI-Device Identifier: 00889795059819
• UDI-Public: (01)00889795059819(17)260922(10)OR9L2AN
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 03/25/2026

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 Catalogue Number: P10-100-BR5L-S
• Device Lot Number: OR9L2AN
• 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: 03/04/2026
• Initial Report FDA Received Date: 03/25/2026
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White