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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL STEM
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EXACTECH, INC. EQUINOXE HUMERAL STEM Back to Search Results
Catalog Number 300-01-13
Device Problem Insufficient Information (3190)
Patient Problems Neuropathy (1983); Complaint, Ill-Defined (2331)
Event Date 05/23/2013
Event Type  Injury  
Event Description
Index surgery: (b)(6) 2013.Dislocated rtsa inpatient with deltoid atony and possible neuropathic joint.Discovered on x-ray on (b)(6) 2013.Patient had no pain.Surgeon performed closed reduction on (b)(6) 2013.This event report was received through clinical data collection activities.
 
Manufacturer Narrative
The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.Engineering evaluation noted that the dislocation reported was likely the result of loosened supporting ligaments and muscles, which is addressed in the product labeling under device specific risks.
 
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Brand Name
EQUINOXE HUMERAL STEM
Type of Device
HUMERAL STEM
Manufacturer (Section D)
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville FL 32653
Manufacturer Contact
graham cuthbert
2320 n.w. 66th ct.
gainesville, FL 32653
MDR Report Key4947334
MDR Text Key6633356
Report Number1038671-2015-00353
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
Reporter Occupation Other
Type of Report Initial
Report Date 07/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number300-01-13
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/24/2015
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 Initial
Patient Sequence Number1
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