MAUDE Adverse Event Report: GRAHAM MEDICAL TECHNOLOGIES, LLC HYPROCURE; HYPROCURE SUBTALAR IMPLANT

Model Number	HYP-05
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	11/26/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A multicenter post market clinical follow-up retrospective study is being performed at specific time points post-implantation to evaluate the safety and performance of the hyprocure subtalar implant, which is used for treatment of talotarsal joint dislocation.The data is gathered by study participants for the time period of september 2020-march 2021.The patient did not have the device removed or a revision surgery.This potential adverse event is noted on the device's instructions for use: "prolonged pain, edema, stiffness, discomfort, and walking difficulty".
Event or Problem Description
Pain, stiffness, discomfort.

• Brand Name: HYPROCURE
• Common Device Name: HYPROCURE SUBTALAR IMPLANT
• Manufacturer (Section D): GRAHAM MEDICAL TECHNOLOGIES, LLC; 16137 leone drive; macomb MI 48042
• MDR Report Key: 11852024
• Report Number: 3004993707-2021-00016
• Device Sequence Number: 19769914
• Product Code: HWC
• UDI-Device Identifier: M621HYP050
• UDI-Public: M621HYP050
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K042030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2021

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: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: HYP-05
• Device Catalogue Number: HYP-05
• Device Lot Number: 05030112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2021
• Initial Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR