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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE TOTAL ANKLE LINER

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EXACTECH, INC. VANTAGE TOTAL ANKLE LINER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 12/03/2019
Event Type  Injury  
Manufacturer Narrative
As reported by the total ankle study database, that a (b)(6) male patient¿s l ankle was initially implanted with a taa on (b)(6) 2019. The patient weighs (b)(6) and is 5¿6¿ tall. The patient visited the er on (b)(6) 2019, complaining of an infection, which was noted by er staff. The patient states a change in his skin appearance began 2-3 weeks before presenting to local er. Debridement and poly exchange only, was performed on (b)(6) 2019. The case report form indicates this event is not related to devices or procedure. This event report was received through clinical data collection activities. All available info has been received at this time. Patient has history of post traumatic arthritis, previous left ankle surgery for fracture and hypertension. Per ifu# (b)(4), superficial or deep infection may be associated with the use of this device. Although some effects are not directly attributable to the device itself, the surgeon should be aware of these potential complications and be ready to treat the patient accordingly. Patients should be instructed on the limitations of the prosthesis and the possibility of subsequent surgery. The patient should be cautioned to monitor activities and protect the replaced joint from unreasonable stresses and follow the written instructions of the physician with respect to follow-up care and treatment. Patients should be warned to protect the joint replacement from unreasonable stresses and to follow the treating physician¿s instructions, until anterior wound healing is complete based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues. The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition or is nosocomial in nature.
 
Event Description
As reported by the total ankle study database, that a (b)(6) male patient¿s l ankle was initially implanted with a total ankle on (b)(6) 2019. The patient weighs (b)(6). And is 5¿6¿ tall. The patient visited the er on (b)(6) 2019, complaining of an infection, which was noted by er staff. The patient states a change in his skin appearance began 2-3 weeks before presenting to local er. Debridement and poly exchange only was performed on (b)(6) 2019. The case report form indicates this event is not related to devices or procedure. This event report was received through clinical data collection activities. All available info has been received at this time. Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues. The cause of the infection and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition or is nosocomial in nature.
 
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Brand NameVANTAGE
Type of DeviceTOTAL ANKLE LINER
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC.
2320 nw 66 ct
gainesville FL 32653
Manufacturer Contact
kate jacobson
3523771140
MDR Report Key9482937
MDR Text Key174661235
Report Number1038671-2019-00607
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 12/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2019
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/17/2019 Patient Sequence Number: 1
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