MAUDE Adverse Event Report: PARAGON 28 TIBIA ARC RT SZ 4 STD 3DP STRL; PROSTHESIS, ANKLE

Catalog Number	P10-100-BR4S-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Pain (1994)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 6 weeks post implantation of a right ankle system, the patient presented with right ankle burning pain and numbness over the right anterior ankle and dorsomedial foot, as well as right ankle anterior incision wound dehiscence.Patient was prescribed gabapentin and treated with wound care and vitamin d.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: p10-250-tlr3-s, talus chamfer rt sz 3 tps strl, lot 260f0082403 10-1306-s, poly component, lot 260f2402311.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 4 STD 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: 24788941
• Report Number: 3008650117-2026-00117
• Device Sequence Number: 18603011
• Product Code: HSN
• UDI-Device Identifier: 00889795059802
• UDI-Public: (01)00889795059802(17)280828(10)260F2402311
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2026

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-BR4S-S
• Device Lot Number: 260F2402311
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/06/2026
• 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; Required Intervention
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White