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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS VAULTLOCK GLENOID TRIAL, X-LARGE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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ARTHREX, INC. UNIVERS VAULTLOCK GLENOID TRIAL, X-LARGE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
Model Number UNIVERS VAULTLOCK GLENOID TRIAL, X-LARGE
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 04/23/2021
Type of Reportable Event Malfunction
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 ar-9236-04pp central peg broke off upon removal of the trial.
 
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Brand Name
UNIVERS VAULTLOCK GLENOID TRIAL, X-LARGE
Common Device Name
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11842510
Report Number1220246-2021-03114
Device Sequence Number3831158
Product Code KWS
UDI-Device Identifier00888867250703
UDI-Public00888867250703
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K161108
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) 05/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberUNIVERS VAULTLOCK GLENOID TRIAL, X-LARGE
Device Catalogue NumberAR-9236-04PP
Device Lot Number1027261711
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/27/2021
Initial Report FDA Received Date05/18/2021
Patient Sequence Number1
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