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

Model Number	HYP-08
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	08/09/2011
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 had undergone a revision surgery to insert a larger implant.
Event or Problem Description
I used to walk and my ankles made a suction cup sound, still walking but no sound.Minimal arch was created.Still uncomfortable barefoot.

• Brand Name: HYPROCURE
• Common Device Name: SUBTALAR IMPLANT
• Manufacturer (Section D): GRAHAM MEDICAL TECHNOLOGIES, LLC DBA GRAMEDICA; 16137 leone drive; macomb MI 48042
• MDR Report Key: 11852028
• Report Number: 3004993707-2021-00019
• Device Sequence Number: 14389523
• Product Code: HWC
• UDI-Device Identifier: M621HYP080
• UDI-Public: M621HYP080
• 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: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• 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: 08/31/2011
• Device Model Number: HYP-08
• Device Catalogue Number: HYP-08
• Device Lot Number: 08NA0407091
• 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: 52 YR