EQUINOXE 320-01-38

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-20 for EQUINOXE 320-01-38 manufactured by Exactech, Inc..

Event Text Entries

[189056337] Pending evaluation. Concomitant device(s): equinoxe reverse tray adapter plate tray +10 (cat# 320-10-10, sn# (b)(4)), stem, liner, screws.
Patient Sequence No: 1, Text Type: N, H10


[189056338] As reported, approximately 11 years postop this male patient? S initial tsa, the patient was revised to a reverse tsa following 6 months of conservative treatment for a fracture. Eight months later, an infection was evident on imaging but not picked up till (b)(6). During a revision to reverse tsa on (b)(6) 2020, all implants were removed, and a second stage revision will be planned. Patient was last known to be in stable condition following the event. Devices not returned due to hospital policy.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1038671-2020-00250
MDR Report Key9860503
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-20
Date of Report2020-03-20
Date of Event2020-02-03
Date Mfgr Received2020-02-03
Date Added to Maude2020-03-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKATE JACOBSON
Manufacturer Phone3523771140
Manufacturer G1EXACTECH, INC.
Manufacturer Street2320 NW 66 CT
Manufacturer CityGAINESVILLE FL 32653
Manufacturer CountryUS
Manufacturer Postal Code32653
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEQUINOXE
Generic NameREVERSE 38MM GLENOSPHERE
Product CodeKWT
Date Received2020-03-20
Model Number320-01-38
Catalog Number320-01-38
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerEXACTECH, INC.
Manufacturer Address2320 NW 66 COURT GAINESVILLE FL 32653 US 32653


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-20

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