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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE GLENOSPHERE
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EXACTECH, INC. EQUINOXE GLENOSPHERE Back to Search Results
Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Joint Disorder (2373); Joint Dislocation (2374); No Code Available (3191)
Event Date 01/29/2018
Event Type  Injury  
Manufacturer Narrative
This event report was received through clinical data collection activities.Pending evaluation.
 
Event Description
Index surgery: (b)(6) 2014.Revision of shoulder components due to dislocation.The case report form indicates this event is possibly related to devices and definitely related to procedure.
 
Event Description
The patient's right shoulder is the operative site.This is one of four products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00217, 1038671-2018-00218, and 1038671-2018-00220.
 
Manufacturer Narrative
This device is used for treatment not diagnosis.The device has not been returned to the manufacturer.
 
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Brand Name
EQUINOXE GLENOSPHERE
Type of Device
GLENOSPHERE
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
MDR Report Key7305981
MDR Text Key101260294
Report Number1038671-2018-00219
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,foreig
Type of Report Initial,Followup
Report Date 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2018
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 Received12/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
Patient Weight95
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