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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; CAGED GLENOID
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EXACTECH, INC. EQUINOXE; CAGED GLENOID Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 03/02/2021
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.Concomitant device(s): humeral head, replicator plate.
 
Event Description
As reported, this (b)(6) y/o female¿s right shoulder caged glenoid failed and was revised.Patient was last known to be in stable condition following the event and the device will be returned for evaluation.
 
Manufacturer Narrative
Section h10: (h3) the revision reported may have been the result of the humeral head articulating posteriorly, creating a shear force on the glenoid component, and leading to fracture of the polyethylene center peg and superior peripheral peg, and partial disengagement of the glenoid.Additional x-rays, such as original post-operative and others from before the revision, were requested and would help confirm the order of events in this case.However, at the time of this evaluation, no additional images were provided.
 
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Brand Name
EQUINOXE
Type of Device
CAGED GLENOID
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key11561745
MDR Text Key242186614
Report Number1038671-2021-00129
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SEE H10.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age72 YR
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