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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. GLENOID, PE WITH PEG, SMALL; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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ARTHREX, INC. GLENOID, PE WITH PEG, SMALL; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
Model Number GLENOID, PE WITH PEG, SMALL
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 09/09/2021
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 performed due to an aseptic loosening of the device.The patient was treated with a shoulder prosthesis change to an inverse shoulder prosthesis.No further information was received.
 
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Brand Name
GLENOID, PE WITH PEG, SMALL
Common Device Name
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key12576497
Report Number1220246-2021-03740
Device Sequence Number3687625
Product Code KWS
UDI-Device Identifier00888867057319
UDI-Public00888867057319
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 company representative,foreig
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 10/05/2021
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 Date06/30/2019
Device Model NumberGLENOID, PE WITH PEG, SMALL
Device Catalogue NumberAR-9105-01
Device Lot Number1427016
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/13/2021
Initial Report FDA Received Date10/05/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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