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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLENOSPHERE 42MM

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EXACTECH, INC. EQUINOXE; GLENOSPHERE 42MM Back to Search Results
Model Number 320-06-42
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 08/08/2021
Event Type  Injury  
Manufacturer Narrative
Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): 300-01-13, equinoxe, humeral stem primary, press fit 13mm; 320-42-00, equinoxe reverse 42mm humeral liner +0; 320-10-00, equinoxe reverse tray adapter plate tray +0; 320-15-01, eq rev glenoid plate.
 
Event Description
As reported, this (b)(6) y/o male patient¿s incurred 2 anterior dislocations.The patient was scheduled for a revision.Patient was last known to be in stable condition following the event.The patient¿s outcome is reported as resolved.All information received from a clinical study database.
 
Manufacturer Narrative
(h3) upon review of the available information, there is no evidence that this is a device related malfunction and there is no allegation against the device.Implantation of a total joint could result scapular notching and dislocation.The most likely cause of the reported event is patient conditions.Section h11: *the following sections have corrected information: (b5) describe event or problem: as reported, this 69 y/o male patient¿s incurred 2 right shoulder anterior dislocations.The patient was scheduled for a revision.Patient was last known to be in stable condition following the event.The patient¿s outcome is reported as resolved.All information received from a clinical study database.The case report form indicates this event is possibly related to devices and/or procedure.This event report was received through clinical data collection activities.(section f) please disregard f10.It were entered in error.
 
Event Description
As reported, this 69 y/o male patient¿s incurred 2 right shoulder anterior dislocations.The patient was scheduled for a revision.Patient was last known to be in stable condition following the event.The patient¿s outcome is reported as resolved.All information received from a clinical study database.The case report form indicates this event is possibly related to devices and/or procedure.This event report was received through clinical data collection activities.
 
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Brand Name
EQUINOXE
Type of Device
GLENOSPHERE 42MM
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC.
2320 nw 66 ct
gainesville FL 32653
Manufacturer Contact
kate jacobson
3523771140
MDR Report Key12868297
MDR Text Key281197756
Report Number1038671-2021-00638
Device Sequence Number1
Product Code KWT
UDI-Device Identifier10885862563712
UDI-Public10885862563712
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/10/2022
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 Health Professional
Device Model Number320-06-42
Device Catalogue Number320-06-42
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/04/2021
Initial Date FDA Received11/24/2021
Supplement Dates Manufacturer Received04/21/2022
Supplement Dates FDA Received05/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age69 YR
Patient SexMale
Patient Weight82 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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