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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQ REV GLENOID PLATE

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EXACTECH, INC. EQUINOXE; EQ REV GLENOID PLATE Back to Search Results
Catalog Number 320-15-01
Device Problems Device Slipped (1584); Device Dislodged or Dislocated (2923)
Patient Problem Fall (1848)
Event Date 12/12/2018
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Revision due to dislocation and loosening.The patient fell and dislocated the shoulder loosening the baseplate.
 
Manufacturer Narrative
Engineering evaluation noted that the revision reported was likely the result of the patient's fall, which led to dislocation and glenoid baseplate loosening.
 
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Brand Name
EQUINOXE
Type of Device
EQ REV GLENOID PLATE
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
Manufacturer (Section G)
EXACTECH
2320 nw 66th court
gainesville FL 32653
Manufacturer Contact
graham cuthbert
2320 nw 66th court
gainesville, FL 32653
3523771140
MDR Report Key8178844
MDR Text Key130794550
Report Number1038671-2018-00965
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/21/2019
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
Device Operator Health Professional
Device Catalogue Number320-15-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2018
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/13/2018
Initial Date FDA Received12/19/2018
Supplement Dates Manufacturer Received12/13/2018
Supplement Dates FDA Received02/21/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age83 YR
Patient Weight83
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