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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLENOSPHERE
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EXACTECH, INC. EQUINOXE; GLENOSPHERE Back to Search Results
Device Problem Break (1069)
Patient Problem Failure of Implant (1924)
Event Date 08/21/2020
Event Type  Injury  
Manufacturer Narrative
Device evaluated by manufacturer? pending evaluation.
 
Event Description
Pending revision for aseptic loosening.Surgery is scheduled for (b)(6) 2020.As reported, this male patient has already been found to have a metal allergy.He has a custom ceramic glenosphere implanted and he did well after the revision.He recently was using crutches to weight bear after a revision total hip replacement.He re-presented with breakage of screws fixing the metaglene.The glenosphere is tilting upward and demonstrating loss of fixation.The surgeon anticipates removal of his metaglene and i will assess his humeral component, which appears well fixed.
 
Manufacturer Narrative
Section h10: therefore, considering this patient's history with a metal allergy, various implants, and the surgeon's statement regarding poor bone quality, the amount of bone left for implant, and that the patient re-injured his shoulder using full weight bearing during physical therapy after a total hip procedure, this is event is determined to be a non-valid complaint.There is no allegation against the device.¿.
 
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Brand Name
EQUINOXE
Type of Device
GLENOSPHERE
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
MDR Report Key10301311
MDR Text Key199653270
Report Number1038671-2020-00359
Device Sequence Number1
Product Code KWT
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received07/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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