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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLENOSPHERE, 36MM

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EXACTECH, INC. EQUINOXE; GLENOSPHERE, 36MM Back to Search Results
Model Number 320-31-36
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Failure of Implant (1924)
Event Date 11/11/2021
Event Type  Injury  
Event Description
As reported, this (b)(6) y/o female patient presented with right shoulder pain.A revision was scheduled.The surgeon removed the humeral tray, liner and glenosphere.He replaced them with a 40+4 glenosphere, neutral liner and a +10 humeral tray.Patient was last known to be in stable condition following the event.Devices will not return due to facility policy.
 
Manufacturer Narrative
Device evaluated by manufacturer? pending evaluation.Concomitant medical device(s): 320-10-00, (b)(4) - equinoxe reverse tray adapter plate tray +0 liner.
 
Manufacturer Narrative
Section h10: h3: 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 the pain and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.
 
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Brand Name
EQUINOXE
Type of Device
GLENOSPHERE, 36MM
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 Key12868089
MDR Text Key281195905
Report Number1038671-2021-00636
Device Sequence Number1
Product Code KWT
UDI-Device Identifier10885862534934
UDI-Public10885862534934
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180632
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/23/2022
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 Number320-31-36
Device Catalogue Number320-31-36
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 Received05/31/2022
Supplement Dates FDA Received06/23/2022
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
Treatment
SEE H10
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age55 YR
Patient SexFemale
Patient Weight85 KG
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