MAUDE Adverse Event Report: PARAGON 28 TIBIA ARC RT SZ 2 LG 3DP STRL; PROSTHESIS, ANKLE

Catalog Number	P10-100-BR2L-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Numbness (2415)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 4 days post implantation of a right total ankle arthroplasty, the patient was experiencing pain and was treated with gabapentin, norco, and bactrim; this was deemed a normal post op finding.Then, approximately 7 months post implantation the patient experienced global pain in the ankle and foot and elected for a steroid injection.Patient had an additional injection 1 month later with no reaction.Approximately 11 months post implantation, patient continued to feel constant pain, along with bothersome numbness on the top of the toes.Attempts have been made and no additional information is available.
Additional Manufacturer Narrative
(b)(4).D10: p10-250-tlr1-s, talus chamfer rt sz 1 tps strl, lot 260f0082402.P10-310-i106-s, x-link vtmn e poly 1x6mm neu strl, lot 26081912301.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.

• Brand Name: TIBIA ARC RT SZ 2 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: 24942446
• Report Number: 3008650117-2026-00191
• Device Sequence Number: 5586142
• Product Code: HSN
• UDI-Device Identifier: 00889795059758
• UDI-Public: (01)00889795059758(17)280705(10)260F18623A04
• 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
• 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): 04/21/2026

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-BR2L-S
• Device Lot Number: 260F18623A04
• 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: 04/06/2026
• Initial 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
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White