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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
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EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM Back to Search Results
Catalog Number 300-01-11
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Osteolysis (2377)
Event Date 09/12/2018
Event Type  Injury  
Manufacturer Narrative
This event report was received through clinical data collection activities.Pending evaluation.
 
Event Description
Index surgery: (b)(6) 2018.Glenoid osteolysis possibly related to a fall 1 week after surgery (not documented, no x-rays done), may compromises glenoid fixation (inferior screws).The case report form indicates this event is unlikely related to devices and unlikely related to procedure.
 
Manufacturer Narrative
Void: this complaint was determined to be non-valid because the reported glenoid osteolysis has been attributed by the surgeon to a patient fall approximately one week post-op.The surgeon also indicated that this event is unlikely related to the devices or the procedure.
 
Manufacturer Narrative
The osteolysis reported in experience was likely the result of the patients reported fall.However, this cannot be confirmed as the devices were not available for evaluation, and no further information was provided.
 
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Brand Name
EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
Type of Device
STEM
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
MDR Report Key8094172
MDR Text Key128019178
Report Number1038671-2018-00901
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
Type of Report Initial,Followup,Followup
Report Date 08/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number300-01-11
Was Device Available for Evaluation? No
Date Manufacturer Received11/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age74 YR
Patient Weight54
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