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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL GLENOID - INLAY LARGE PLUS; SHOULDER PROSTHESIS, REVERSE CONFIGURATION
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ARTHREX, INC. UNIVERSAL GLENOID - INLAY LARGE PLUS; SHOULDER PROSTHESIS, REVERSE CONFIGURATION Back to Search Results
Model Number UNIVERSAL GLENOID - INLAY LARGE PLUS
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 07/21/2021
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 a revision surgery was necessary as the glenoid component abraded.The shoulder prosthesis was changed to an inverse prosthesis.No further information received.
 
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Brand Name
UNIVERSAL GLENOID - INLAY LARGE PLUS
Common Device Name
SHOULDER PROSTHESIS, REVERSE CONFIGURATION
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key12300879
Report Number1220246-2021-03507
Device Sequence Number16935117
Product Code PHX
UDI-Device Identifier00888867057463
UDI-Public00888867057463
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K182039
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 08/10/2021
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 Expiration Date07/31/2015
Device Model NumberUNIVERSAL GLENOID - INLAY LARGE PLUS
Device Catalogue NumberAR-9121-06
Device Lot Number1031006
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/22/2021
Initial Report FDA Received Date08/10/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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