MAUDE Adverse Event Report: PARAGON 28 TALUS FLAT RT SZ 2 TPS STRL; PROSTHESIS, ANKLE

Catalog Number	P10-251-TLR2-S
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002); Implant subsidence (4078)
Health Effect - Clinical Codes	Pain (1994); Scar Tissue (2060); Osteopenia/ Osteoporosis (2651); Swelling/ Edema (4577); Joint Impingement (4834); Aseptic loosening (4883); Exostosis (bone) (4891)
Date of Event	04/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) d10 p10-101-br3s-s, tibia flat rt sz 3 std 3dp strl, lot 260f14923a16.P10-310-i210-s, x-link vtmn e poly 2x10mm neu strl, lot 260832520a02.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that approximately 14 months post implantation of a right ankle prosthesis system, the patient presented with pain and swelling of the right ankle.Patient was diagnosed with posterior subsidence of the talar component, and noted to be a failed right total ankle arthroplasty with aseptic loosening.Patient was treated with ankle bracing and lidocaine injection, and noted to be recovering/resolving.Attempts have been made and all available information has been provided.
Event or Problem Description
It was further 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
This follow-up report is being submitted to relay additional information.The following sections were updated: a1, b1, b3, b4, b5, e1, g3, h2, h6 b1: previously reported as product problem, however, no device problem has been identified upon patient's revision.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.

• Brand Name: TALUS FLAT RT SZ 2 TPS 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: 24705359
• Report Number: 3008650117-2026-00082
• Device Sequence Number: 10467174
• Product Code: HSN
• 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
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: P10-251-TLR2-S
• Device Lot Number: 260F3002303
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 06/18/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 210 LB
• Patient Race: White