MAUDE Adverse Event Report: ARTHREX, INC. GLENOID, PE WITH PEG, SMALL; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	GLENOID, PE WITH PEG, SMALL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
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 due to a loosening of the glenoid component and a central glenoid defect.No further information received.
Additional Manufacturer Narrative
The loosening of the glenoid poly could not be confirmed with the information available.The device is not visible on x-ray.The device was returned and was found to be cracked and chipped around the edges.The spherical surface is worn and cracked.Traces of bone cement were found around the keel and the pegs are slightly bent but not broken.The cause of the event is undetermined.

• 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 Key: 11235363
• Report Number: 1220246-2021-02508
• Device Sequence Number: 11797571
• Product Code: KWS
• UDI-Device Identifier: 00888867057319
• UDI-Public: 00888867057319
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: GLENOID, PE WITH PEG, SMALL
• Device Catalogue Number: AR-9105-01
• Device Lot Number: 1409020
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 08/02/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other