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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REVERSE HUMERAL LINER
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EXACTECH, INC. EQUINOXE REVERSE HUMERAL LINER Back to Search Results
Catalog Number 320-46-00
Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Joint Dislocation (2374); Patient Problem/Medical Problem (2688); No Code Available (3191)
Event Date 10/24/2018
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Index surgery: (b)(6) 2017.Revision of shoulder components due to instability.This event report was received through clinical data collection activities.
 
Manufacturer Narrative
Correction.Explant date was (b)(6) 2018.
 
Event Description
It was reported on (b)(6) 2018 by the equinoxe shoulder study database that the patient describes history of at least 3-5 anterior instability events.The patient also states the subluxations that are self reduced.The patient was scheduled and will have left shoulder revision surgery.And the revision was completed on (b)(6) 2018.The case report form indicates this event is possibly related to devices and definitely related to procedure.This event report was received through clinical data collection activities., which also indicate the problem is resolved.
 
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Brand Name
EQUINOXE REVERSE HUMERAL LINER
Type of Device
LINER
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
MDR Report Key7344621
MDR Text Key102586707
Report Number1038671-2018-00240
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
K082702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,study
Type of Report Initial,Followup
Report Date 12/04/2018
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 Catalogue Number320-46-00
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/08/2018
Initial Date FDA Received03/16/2018
Supplement Dates Manufacturer Received11/19/2018
Supplement Dates FDA Received12/04/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age59 YR
Patient Weight95
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