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

Model Number HYP-06

Device Problems Loose or Intermittent Connection (1371); Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/03/2017

Event Type  Injury  

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 implant.The pmcf studies were not requested by fda.The manufacturer was not made aware of these issues prior to the report study and no complaints have been made.The device instructions for use includes a warning - it is very important to selct the correct size of the implant to achieve the best possible correction.All risks have been reduced as low as possible.

Event Description

Migration.

• Brand Name: HYPROCURE
• Type of Device: SUBTALAR IMPLANT
• Manufacturer (Section D): GRAHAM MEDICAL TECHNOLOGIES LLC, DBA GRAMEDICA; 16137 leone drive; macomb MI 48042
• Manufacturer (Section G): GRAHAM MEDICAL TECHNOLOGIES, LLC DBA GRAMEDICA; 16137 leone drive; macomb MI 48042
• Manufacturer Contact: angela recchia ; 16137 leone drive; macomb, MI 48042 ; 5866779600
• MDR Report Key: 11852044
• MDR Text Key: 251672089
• Report Number: 3004993707-2021-00025
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2021
• Device Model Number: HYP-06
• Device Catalogue Number: HYP-06
• Device Lot Number: 060523161
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2021
• Initial Date FDA Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR