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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS VAULTLOCK GLENOID TRIAL, LARGE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

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ARTHREX, INC. UNIVERS VAULTLOCK GLENOID TRIAL, LARGE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
Model Number UNIVERS VAULTLOCK GLENOID TRIAL, LARGE
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/08/2022
Event Type  malfunction  
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 Description
On 7/08/2022 it was reported by a sales representative via sems that an ar-9236-03pp vaultlock glenoid trial became stuck in the glenoid and when it was removed the central peg was broken.Another trial was inserted and the same event occurred.The broken parts were removed from the patient.The bone quality was normal.The procedure was completed with no patient affect.
 
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Brand Name
UNIVERS VAULTLOCK GLENOID TRIAL, LARGE
Type of Device
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key15093693
MDR Text Key302086050
Report Number1220246-2022-05301
Device Sequence Number1
Product Code KWS
UDI-Device Identifier00888867250697
UDI-Public00888867250697
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 07/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUNIVERS VAULTLOCK GLENOID TRIAL, LARGE
Device Catalogue NumberAR-9236-03PP
Device Lot Number1027261805
Was Device Available for Evaluation? No
Date Manufacturer Received07/08/2022
Date Device Manufactured04/02/2018
Is the Device Single Use? No
Type of Device Usage Initial
Patient Sequence Number1
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