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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE HUMERAL LINER, CONSTRAINED
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EXACTECH, INC. EQUINOXE REVERSE HUMERAL LINER, CONSTRAINED Back to Search Results
Catalog Number 320-46-10
Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Joint Disorder (2373); Joint Dislocation (2374); No Code Available (3191)
Event Date 05/03/2018
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Revision due to dislocation.
 
Manufacturer Narrative
In a review of the labeling it is a known complication that a patient's age, weight, or activity level 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 cause of the shoulder dislocation is most likely related to the patient's underlying conditions.This device is used for treatment not diagnosis.
 
Event Description
No additional information provided.This is one of four products involved with the reported event and the associated manufacturer report numbers are 1038671-2018-00440, 1038671-2018-00441, and 1038671-2018-00455.
 
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Brand Name
EQUINOXE REVERSE HUMERAL LINER, CONSTRAINED
Type of Device
LINER
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
MDR Report Key7499674
MDR Text Key107767839
Report Number1038671-2018-00442
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
K063569
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date08/06/2022
Device Catalogue Number320-46-10
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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