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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. GLENOID, PE WITH PEG, MEDIUM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
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ARTHREX, INC. GLENOID, PE WITH PEG, MEDIUM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED Back to Search Results
Model Number GLENOID, PE WITH PEG, MEDIUM
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 11/09/2020
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 surgery was performed because of loosening of polyethylene glenoid with destruction of local glenoid.
 
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Brand Name
GLENOID, PE WITH PEG, 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 Key11003956
Report Number1220246-2020-02404
Device Sequence Number11715779
Product Code KWS
UDI-Device Identifier00888867057326
UDI-Public00888867057326
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,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/14/2020
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 Expiration Date10/31/2019
Device Model NumberGLENOID, PE WITH PEG, MEDIUM
Device Catalogue NumberAR-9105-02
Device Lot Number1448011
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/23/2020
Initial Report FDA Received Date12/14/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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