MAUDE Adverse Event Report: ARTHREX INC. UNIVERS REVERSE GLENOSPHERE 39 + 4 LAT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	AR-9504M-04
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	02/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
This is an automated communication received directly from a patient in the surgical outcome system study.The surgeon also receives this report and is instructed to notify product surveillance of any arthrex product involvement.An email has been sent to the surgeon requesting further details if product related.Follow-up investigation: it was reported that the patient underwent a reverse tsa with glenoid graft procedure on (b)(6) 2017.The patient had an early glenoid and graft failure and a revision surgery was performed on (b)(6) 2018.The surgeon performed a simple revision with removal of the fragmented graft and medialization of the baseplate.The surgeon stated that with the patient's medialized base plate he will develop some notching and his motion will not be as good as it could have been.

• Brand Name: UNIVERS REVERSE GLENOSPHERE 39 + 4 LAT
• 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: 7380855
• Report Number: 1220246-2018-00109
• Device Sequence Number: 1426562
• Product Code: KWS
• UDI-Device Identifier: 00888867061378
• UDI-Public: 00888867061378
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K143749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2018

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 Date: 07/01/2022
• Device Catalogue Number: AR-9504M-04
• Device Lot Number: 170044914
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other