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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL STEM, PRIMARY, PRESS FIT
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EXACTECH, INC. EQUINOXE HUMERAL STEM, PRIMARY, PRESS FIT Back to Search Results
Catalog Number 300-01-13
Device Problem Insufficient Information (3190)
Patient Problem Inflammation (1932)
Event Date 02/24/2014
Event Type  Other  
Event Description
A pt with equinoxe shoulder components was reported to have had rotator cuff tendinitis.This event was reported through clinical data collection.Primary surgery was on (b)(6) 2011.
 
Manufacturer Narrative
The contribution of the devices to the experience reported could not be determined as the devices remained implanted.Additionally, the device specific identification information was not provided, precluding a review of the device history record.
 
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Brand Name
EQUINOXE HUMERAL STEM, PRIMARY, PRESS FIT
Type of Device
HUMERAL STEM, PRIMARY, PRESS FIT
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
8003922832
MDR Report Key3716550
MDR Text Key4227645
Report Number1038671-2014-00086
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Reporter Country CodeUS
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 03/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/24/2014
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
Patient Outcome(s) Hospitalization; Required Intervention;
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