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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. GLENOSPHERE 38MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
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EXACTECH, INC. GLENOSPHERE 38MM; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
Catalog Number 320-06-38
Device Problem Insufficient Information (3190)
Patient Problem Failure of Implant (1924)
Event Date 09/12/2023
Event Type  Injury  
Manufacturer Narrative
Pending investigation.
 
Event Description
As reported, the patient had an initial left tsa on an unknown date.A conversion of anatomic to reverse occurred on (b)(6) 2023.There was no reported surgical delay/prolongation.The patient was last known to be in stable condition following the event.
 
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Brand Name
GLENOSPHERE 38MM
Type of Device
PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC.
2320 nw 66th ct
gainesville FL 32653
Manufacturer Contact
kate jacobson
2320 nw 66th ct
gainesville, FL 32653
3523771140
MDR Report Key17873791
MDR Text Key324959319
Report Number1038671-2023-02454
Device Sequence Number1
Product Code KWT
UDI-Device Identifier10885862563699
UDI-Public10885862563699
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 10/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number320-06-38
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/14/2023
Was Device Evaluated by Manufacturer? No
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) Required Intervention;
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