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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE GLENOID
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EXACTECH, INC. EQUINOXE GLENOID Back to Search Results
Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Revision due to disassociation of the glenoid component.
 
Event Description
It was reported that the patient fell on his shoulder at a worksite.He was reported to "be 4 months out".The trauma caused disassociation of the poly from the pegs.There is no indication that the devices malfunctioned.No additional information is provided.
 
Manufacturer Narrative
In a review of the labeling it is a known complication that a patient's age, weight, trauma or activity level would cause the surgeon to expect early failure of the system.Revisions or surgical interventions are a known complication found in joint replacements.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 most likely cause of the revision for the shoulder joint device is related to trauma from the patient fall.This device is used for treatment, not diagnosis.
 
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Brand Name
EQUINOXE GLENOID
Type of Device
GLENOID
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
MDR Report Key6890408
MDR Text Key87210491
Report Number1038671-2017-00699
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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