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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10
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EXACTECH, INC. EQUINOXE; EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10 Back to Search Results
Catalog Number 320-10-10
Health Effect - Clinical Code No Code Available (3191)
Date of Event 03/20/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
 
Event or Problem Description
Revision due to dislocation.
 
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of loosened supporting ligaments and muscles, which allowed for dislocation.
 
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Brand Name
EQUINOXE
Common Device Name
EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key8513705
Report Number1038671-2019-00235
Device Sequence Number1884897
Product Code KWT
UDI-Device Identifier10885862086433
UDI-Public10885862086433
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K063569
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number320-10-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/21/2019
Supplement Date Received by Manufacturer10/16/2019
Initial Report FDA Received Date04/15/2019
Supplement Report FDA Received Date11/19/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age85 YR
Patient Weight91
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