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

Model Number	HYPII-11
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/04/2021
Type of Reportable Event	Serious Injury
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.The device instructions for use (ifu) includes warnings - specifically, it is very important to select the correct size of the implant to achieve the best possible correction and a very critical part of the surgery is complete cutting of the talocalcaneal ligament deep in the canalis portion of the sinus tarsi.
Event or Problem Description
The patient described being 'very satisfied' with the device.At 2 weeks post-op appointment, the implant had a slight lateral deviation and surgical revision was scheduled.

• Brand Name: HYPROCURE II 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: 14222002
• Report Number: 3004993707-2022-00002
• Device Sequence Number: 14484241
• 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: K142534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 04/01/2022

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: 07/10/2022
• Device Model Number: HYPII-11
• Device Catalogue Number: HYPII-11
• Device Lot Number: 110221171
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2017
• 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): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Sex: Female