MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL REVERSE GLENOSPHERE 36 +4 LAT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	AR-9504S-04
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (date of birth, 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.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.Device history record review revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Device reported to have been discarded.
Event or Problem Description
It was reported that the patient underwent a univers revers shoulder procedure in (b)(6) 2016.Per event reporter the patient is pre-diabetic, has long term systemic steroid use, and very poor tissue quality.The glenosphere became disassociated and a revision surgery was done on (b)(6) 2017.The humeral stem and baseplate were intact and solid.The glenosphere, ar-9504s-04, lot 150033709 ((b)(4)) and humeral cup ar-9502-36cpc, lot 2501495810 ((b)(4)) were extracted from the patient and replaced with the same sizes as used previously, however, the surgeon replaced the +3 univers revers humeral insert ar-9503s-03, lot 140115507 ((b)(4)) with a +6 constrained liner to increase stability.

• Brand Name: UNIVERSAL REVERSE GLENOSPHERE 36 +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: 6607838
• Report Number: 1220246-2017-00182
• Device Sequence Number: 1266604
• Product Code: KWS
• UDI-Device Identifier: 00888867061408
• UDI-Public: 00888867061408
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K143749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/02/2017

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: 03/01/2020
• Device Catalogue Number: AR-9504S-04
• Device Lot Number: 150033709
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2017
• Initial Report FDA Received Date: 06/02/2017
• 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-9502-36CPC LOT 2501495810 UNIVERSAL REVERSE CUP; AR-9503S-03 LOT 140115507 HUMERAL INSERT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR