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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS VAULTLOCK GLENOID, MEDIUM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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ARTHREX, INC. UNIVERS VAULTLOCK GLENOID, MEDIUM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
Model Number UNIVERS VAULTLOCK GLENOID, MEDIUM
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 02/05/2021
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.
 
Event or Problem Description
It was reported that the central peg broke off the ar-9106-02 when the surgeon was putting the bone graft on the peg.Another ar-9106-02 was used to complete the total shoulder case.
 
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Brand Name
UNIVERS VAULTLOCK GLENOID, MEDIUM
Common Device Name
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11358148
Report Number1220246-2021-02613
Device Sequence Number19153487
Product Code KWS
UDI-Device Identifier00888867239326
UDI-Public00888867239326
Combination Product (Y/N)N
Initial Reporter StateMI
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) 02/22/2021
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? Yes
Operator of Device Health Professional
Device Expiration Date10/31/2024
Device Model NumberUNIVERS VAULTLOCK GLENOID, MEDIUM
Device Catalogue NumberAR-9106-02
Device Lot Number1027261930
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/05/2021
Initial Report FDA Received Date02/22/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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