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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HEMI SHOULDER COMPONENTS
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EXACTECH, INC. EQUINOXE; HEMI SHOULDER COMPONENTS Back to Search Results
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Pain (1994); Non-union Bone Fracture (2369); Impaired Healing (2378); No Information (3190)
Event Date 05/24/2017
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Approximately 10 months postop tsa, this (b)(6) y/o female experienced a revision to a hemi due extreme pain in shoulder due to humeral loosening and non-union with aseptic humeral loosening.The humeral liner and tray were replaced.The patient has history of hypertension.The case report form indicates this event was resolved with revision surgery on (b)(6) 2018.Devices will not return due to study.This event report was received through clinical data collection activities.The case report form indicates this event is unlikely related to devices and definitely related to procedure.
 
Manufacturer Narrative
Section h10: (h3) upon review, there is no allegation against the device as the reason for revision was not reported.The most likely cause of the reported event is unknown at this time.(h6) evaluation codes: 3190, 2993.
 
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Brand Name
EQUINOXE
Type of Device
HEMI SHOULDER COMPONENTS
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key9920421
MDR Text Key186286392
Report Number1038671-2020-00266
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 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received10/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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