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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC EQUINOXE REVERSE HUMERAL ADAPTER TRAY
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EXACTECH, INC EQUINOXE REVERSE HUMERAL ADAPTER TRAY Back to Search Results
Catalog Number 320-10-00
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Joint Disorder (2373); No Code Available (3191)
Event Date 11/04/2016
Event Type  Injury  
Manufacturer Narrative
The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, device specific information was not provided, precluding a review of the device history record.
 
Event Description
Index surgery (b)(6) 2016.Revision due to glenoid loosening.The case report form indicates the event is definitely not related to devices and definitely not related to procedure.This event report was received through clinical data collection activities.
 
Manufacturer Narrative
The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, device specific information was not provided, precluding a review of the device history record.Engineering evaluation noted that the revision reported was likely the result of aseptic (non-infected) glenoid loosening.
 
Event Description
Index surgery: (b)(6) 2016.Revision due to aseptic glenoid loosening.The case report form indicates this event is definitely not related to devices or procedure.This event report was received through clinical data collection activities.
 
Manufacturer Narrative
The contribution of the devices to the experience reported could not be determined as the devices were not returned for evaluation.Additionally, device specific information was not provided, precluding a review of the device history record.Engineering evaluation noted that the revision reported was likely the result of aseptic (non-infected) glenoid loosening.
 
Event Description
Index surgery: (b)(6) 2016.Revision due to aseptic glenoid loosening.The case report form indicates this event is definitely not related to devices or procedure.This event report was received through clinical data collection activities.
 
Event Description
It was reported from france about experienced glenoid loosening on the left shoulder with complaints of increased pain "since 6 months post-op".There is no indication or complaint that the devices malfunctioned.No additional information is provided.This is one of six products involved with the reported event and the associated manufacturer report numbers are 1038671-2016-00815, 1038671-2016-00817, 1038671-2016-00818, 1038671-2016-00819 and 1038671-2017-00825.
 
Manufacturer Narrative
After further review of additional information received the following sections race, date of report, event, relevant tests/laboratory data, other relevant history, date rec¿d by mfr, pma/510k, if follow-up, what type and adverse event problem have been updated accordingly.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.As part of the preoperative assessment, the surgeon must ensure that no biological, biomechanical, or other factors exist that might adversely affect the surgery and/or postoperative period.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 glenoid loosening of the left shoulder joint devices is most likely due to the patient's underlying conditions to include previous shoulder maladies.This device is used for treatment, not diagnosis.There is no information ethnicity, serial and expiration date and device manufacture date.
 
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Brand Name
EQUINOXE REVERSE HUMERAL ADAPTER TRAY
Type of Device
HUMERAL ADAPTER TRAY
Manufacturer (Section D)
EXACTECH, INC
2320 nw 66th ct
gainesville FL 32653
MDR Report Key6142550
MDR Text Key61360220
Report Number1038671-2016-00816
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,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 01/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Catalogue Number320-10-00
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
Patient Weight75
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