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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 07/12/2021
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 on (b)(6) 2021 due to an aseptic loosening of the device.During the revision surgery the patient was treated by removing the glenoid implant and filling the bone defect with cerement.No further information 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 Key12268128
Report Number1220246-2021-03470
Device Sequence Number3531668
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 foreign,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/03/2021
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 Number1427002
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/14/2021
Initial Report FDA Received Date08/03/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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