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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE HUMERAL HEAD, SHORT

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EXACTECH, INC. EQUINOXE HUMERAL HEAD, SHORT Back to Search Results
Catalog Number 310-01-47
Device Problems Loose or Intermittent Connection (1371); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Failure of Implant (1924)
Event Date 08/16/2017
Event Type  Injury  
Manufacturer Narrative
The contribution of the devices to the experience reported could not be determined as the device was not returned.Pending evaluation.
 
Event Description
Index surgery: (b)(6) 2012.Revision due to patient fall, causing the poly to become loose on the glenoid side.
 
Event Description
Due to an insufficient rotator cuff, the surgeon had decided to remove all the primary components, except for the humeral stem and perform a reverse shoulder.No additional information provided.This is one of four products involved with the reported event and the associated manufacturer report numbers are 1038671-2017-00627, 1038671-2017-00628, and 1038671-2017-00630.
 
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.
 
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Brand Name
EQUINOXE HUMERAL HEAD, SHORT
Type of Device
HUMERAL HEAD
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
MDR Report Key6812907
MDR Text Key83366339
Report Number1038671-2017-00629
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
K042021
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
Device Expiration Date05/17/2022
Device Catalogue Number310-01-47
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/18/2017
Initial Date FDA Received08/23/2017
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 Age80 YR
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