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

Catalog Number	P10-100-BR3L-S
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994); Osteolysis (2377); Aseptic loosening (4883)
Date of Event	05/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: p10-251-tlr1-s, talus flat rt sz 1 tps strl, lot 260f1942405.P10-310-i108-s, x-link vtmn e poly 1x8mm neu strl, lot 26080992402.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.
Event or Problem Description
It was reported that approximately 6 months post implantation of a right ankle prosthesis, the patient presented with shin splint-type pain along the lateral and anterior aspects of the right ankle.Ct scan showed cystic changes under the tibial plate.Loosening of the tibial component is suspected but not confirmed.Patient was treated with a cam boot.Attempts have been made and all available information has been provided.
Event or Problem Description
It was further reported that approximately 1 year post implantation of a right total ankle arthroplasty, the patient underwent revision due to pain and tibial implant loosening.All components were revised with competitor products.Attempts for additional information have been made and all has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a1, b3, b4, b5, d6b, e1, g3, h2, h6.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: TIBIA ARC RT SZ 3 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: 24687928
• Report Number: 3008650117-2026-00077
• Device Sequence Number: 15916359
• 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: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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: P10-100-BR3L-S
• Device Lot Number: 260F3332312
• 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
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 06/22/2026
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 237 LB
• Patient Race: White