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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA)
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EXACTECH, INC. EQUINOXE; EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA) Back to Search Results
Catalog Number 310-01-44
Device Problem Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2019
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Index surgery: (b)(6) 2017.The prosthesis was discovered to be sitting proud and therefore had to be revised.
 
Manufacturer Narrative
Engineering evaluation noted that the revision reported was likely the result of implanting an oversized humeral stem, which led to the humeral stem sitting proud.However, this cannot be confirmed as the devices were not available for evaluation and x-rays were not provided.
 
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Brand Name
EQUINOXE
Type of Device
EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA)
Manufacturer (Section G)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
Manufacturer Contact
graham cuthbert
2320 nw 66th court
gainesville, FL 32653
3523771140
MDR Report Key8270308
MDR Text Key133842528
Report Number1038671-2019-00010
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
Reporter Country CodeUK
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
Date FDA Received01/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number310-01-44
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/10/2019
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;
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