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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE SHOULDER COMPONENTS

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EXACTECH, INC. EQUINOXE SHOULDER COMPONENTS Back to Search Results
Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fall (1848)
Event Date 09/07/2017
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Revision due to dislocation after a fall.
 
Manufacturer Narrative
In a review of the labeling it is a known complication that a patient's age, weight, activity level, or trauma would cause the surgeon to expect early failure of the system.Revisions or surgical interventions are a known complication found in joint replacements.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The most likely cause of the revision for the shoulder joint device is related the patient fall.This device is used for treatment, not diagnosis.
 
Event Description
The patient fell and dislocated the poly from the tray, the ploy was replaced.The implant was stated to be "5 years old".There is no indication that the devices malfunctioned.No additional information is provided.
 
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Brand Name
EQUINOXE SHOULDER COMPONENTS
Type of Device
SHOULDER COMPONENTS
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
MDR Report Key6887567
MDR Text Key87156981
Report Number1038671-2017-00698
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
Report Date 01/15/2019
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 Physician
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/08/2017
Initial Date FDA Received09/22/2017
Supplement Dates Manufacturer Received01/15/2019
Supplement Dates FDA Received01/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age81 YR
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