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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. HUMERAL HEAD

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EXACTECH, INC. HUMERAL HEAD Back to Search Results
Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fall (1848)
Event Date 08/24/2017
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Patient fell.Revised due to failed glenoid.
 
Event Description
It was reported that the patient fell and most likely caused the anatomic glenoid cage to break in several pieces and the poly to come loose.The patient was converted to a reverse shoulder and everything was reported to look good.There is no indication that the devices malfunctioned.No additional information is provided.This is one of four products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00797, 1038671-2017-00801, 1038671-2017-00802.
 
Manufacturer Narrative
In a review of the labeling it is a known complication that a patient's age, weight, activity level and/or trauma 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
HUMERAL HEAD
Type of Device
HEAD
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
MDR Report Key7000298
MDR Text Key90996668
Report Number1038671-2017-00803
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
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
Initial Date Manufacturer Received 08/25/2017
Initial Date FDA Received11/03/2017
Supplement Dates Manufacturer Received01/15/2019
Supplement Dates FDA Received01/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
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