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

Catalog Number	AR-9504M-04
Health Effect - Clinical Code	Fall (1848)
Date of Event	02/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The device was requested for evaluation but was not returned, 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.Device history record review revealed nothing relevant to this event.The most likely cause(s) of this type of event was that that the patient had a fall after surgery and the implant backed out of the patient's shoulder.The directions for use states: post-operatively, until healing is complete the fixation provided by this device should be protected.The post-operative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the implant.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
It was reported that the patient had a fall after surgery and the implant backed out of the patient's shoulder.A revision has been scheduled but the date has not yet been confirmed.Please see attached x-rays.No further details, additional information has been requested.Follow-up investigation: implants that were removed were ar-9504m-04, lot: 170036414 (line 225343) and ar-9503m-03, lot: 170041310 (line: 227698) date of original surgery was (b)(6) 2018.Date of revision was (b)(6) 2018.The surgeon wanted to keep implants.The patient fell 6 weeks post-op.

• Brand Name: UNIVERS REVERS 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: 7422076
• Report Number: 1220246-2018-00126
• Device Sequence Number: 1094345
• Product Code: KWS
• UDI-Device Identifier: 00888867061378
• UDI-Public: 00888867061378
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

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: 05/01/2022
• Device Catalogue Number: AR-9504M-04
• Device Lot Number: 170036414
• 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: 03/19/2018
• Initial Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AR-9503M-03, HUMERAL INSERT, LOT 170041310
• Outcome Attributed to Adverse Event: Other