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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. 33 +4 LAT/24 GLENOSPHERE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION
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ARTHREX, INC. 33 +4 LAT/24 GLENOSPHERE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION Back to Search Results
Model Number 33 +4 LAT/24 GLENOSPHERE
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/04/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
 
Event or Problem Description
It was reported that the patient had a reverse shoulder case done in (b)(6) 2020.Due to infections, all the devices were removed on (b)(6) 2021.An antibiotic spacer was placed at the site; there may be a shoulder revision done in the future.Removed ar-9501-05p, ar-9502f-36rcpc, ar-9564-2433-lat, ar-9503-3633-3c, ar-9560-24, ar-9561-30s.
 
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Brand Name
33 +4 LAT/24 GLENOSPHERE
Common Device Name
SHOULDER PROSTHESIS, REVERSE CONFIGURATION
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11871900
Report Number1220246-2021-03135
Device Sequence Number10993516
Product Code PHX
UDI-Device Identifier00888867295650
UDI-Public00888867295650
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
K173900
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 05/24/2021
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
Operator of Device Health Professional
Device Model Number33 +4 LAT/24 GLENOSPHERE
Device Catalogue NumberAR-9564-2433-LAT
Device Lot Number19.02946
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/04/2021
Initial Report FDA Received Date05/24/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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