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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. GLENOID, PE WITH PEG, LARGE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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ARTHREX, INC. GLENOID, PE WITH PEG, LARGE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
Model Number GLENOID, PE WITH PEG, LARGE
Health Effect - Clinical Code No Information (3190)
Date of Event 05/02/2019
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.
 
Event or Problem Description
It was reported that a revision shoulder surgery was performed on (b)(6) 2019.The glenoid got loose post op.No further information provided by the customer.The device will not return for investigation.
 
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Brand Name
GLENOID, PE WITH PEG, 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 Key9738731
Report Number1220246-2020-01676
Device Sequence Number10854533
Product Code KWS
UDI-Device Identifier00888867057333
UDI-Public00888867057333
Combination Product (Y/N)N
Initial Reporter CountrySZ
PMA/510(K) Number
K083435
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 02/21/2020
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 NumberGLENOID, PE WITH PEG, LARGE
Device Catalogue NumberAR-9105-03
Device Lot Number1032011
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/28/2020
Initial Report FDA Received Date02/21/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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