MAUDE Adverse Event Report: ARTHREX INC. UNIVERS REVERS GLENOSPHERE 42 +4 LAT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	AR-9504L-04
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	03/08/2018
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/is expected for evaluation but has not yet been received.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 the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that the patient underwent a univers reverse tsa on (b)(6) 2018.The same surgeon performed a revision univers reverse tsa procedure on (b)(6) 2018 due to the glenosphere disassociating from the baseplate at the morse taper.Follow-up investigation: an l/42 humeral insert (ar-9503l-03 / lot: 170016710, line 226431) and an 42+4 univers revers glenosphere (ar-9504l-04 / lot: 17009813, line 226918) were implanted during the original procedure on (b)(6) 2018 and explanted during the revision surgery on (b)(6) 2018.X-rays were taken however, not yet provided.The explanted hardware was replaced with the following: ar-9404l-04, lot: 170009813.Ar-9503l-06, lot: 170005010.

• Brand Name: UNIVERS REVERS GLENOSPHERE 42 +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: 7398758
• Report Number: 1220246-2018-00117
• Device Sequence Number: 13879317
• Product Code: KWS
• UDI-Device Identifier: 00888867061347
• UDI-Public: 00888867061347
• 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: 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): 04/05/2018

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: 04/01/2022
• Device Catalogue Number: AR-9504L-04
• Device Lot Number: 170009813
• 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: 03/12/2018
• Initial Report FDA Received Date: 04/05/2018
• 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