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

Model Number	HYP-07
Medical Device Problem Codes	Patient-Device Incompatibility (2682); No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient noted this device limited mobility in my right foot and ankle considerably.
Additional Manufacturer Narrative
A multi-center post market clinical follow-up (pmcf) retrospective study is being performed at specific time points post implantation to evaluate the safety and performance of the hyprocure implant.The pmcf studies were not requested by fda.The manufacturer was not made aware of this patient issue prior to the report study and no complaints have been made.Lot numbers and serial numbers are unknown, therefore the device history record review could not be completed.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This data will be monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.

• Brand Name: HYPROCURE SINUS TARSI IMPLANT SYSTEM
• Common Device Name: SUBTALAR IMPLANT
• Manufacturer (Section D): GRAHAM MEDICAL TECHNOLOGIES, LLC DBA GRAMEDICA; 16137 leone drive; macomb MI 48042 4063
• Manufacturer Contact: angela recchia ; 16137 leone drive; macomb, MI 48042-4063 ; 5866779600
• MDR Report Key: 16814927
• Report Number: 3004993707-2023-00003
• Device Sequence Number: 5695259
• Product Code: HWC
• UDI-Device Identifier: M621HYPII110
• UDI-Public: +M621HYPII110
• 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 Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 04/21/2023

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 Model Number: HYP-07
• Device Catalogue Number: HYP-07
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Female