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

Catalog Number	AR-9105-03
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/20/2017
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.This is the first complaint of this type for this part/lot combination.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 underwent a total shoulder procedure on (b)(6) 2014.Three years post-op, the ar-9105-03, glenoid, pe with peg, large, lot 1432001 that was implanted broke.The patient underwent a second surgery on (b)(6) 2017 during which the broken glenoid was explanted.The pegs and keel seemed to have sheared off.There was no traumatic event that caused the glenoid to fail (i.E.Patient falling).The broken glenoid was removed and no devices were implanted.The pegs and keel were retrieved from the patient.Surgeon used a grasper to pull them out.The device was discarded by the facility.Pictures of the device have been provided.The surgeon performed a routine arthroscopy to remove the implant.Surgeon then left the patient as is to see if the patient could manage without another open procedure.Follow-up investigation: the patient came back in (b)(6) 2017 to have a revision tsa.During the (b)(6) 2017 revision tsa the surgeon had to explant the original ar-9154-21p, usp ii humeral head, lot 2501401412, and the trunion portion of the original ar-9100-10s, univers apex humeral stem, lot 1192182.This was to gain access to be able to implant a new glenoid.These explanted devices looked ok but the surgeon chose to implant brand new devices with the new glenoid.The following devices were implanted during the (b)(6) 2017 second revision procedure: ar-9100tk, univers ii trunion kit, lot 160060411; ar-9105-03 univers glenoid poly with peg, lot 113601641; ar-9150-19p, univers ii humeral head, lot 170031621.None of the explanted devices from either revision will be returned for evaluation.Patient is a male.

• Brand Name: GLENOID, PE WITH PEG, LARGE
• 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: 7178419
• Report Number: 1220246-2017-00513
• Device Sequence Number: 1250324
• Product Code: KWS
• UDI-Device Identifier: 00888867057333
• UDI-Public: 00888867057333
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K083435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 01/10/2018

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: 07/01/2019
• Device Catalogue Number: AR-9105-03
• Device Lot Number: 1432001
• 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: 12/22/2017
• Initial Report FDA Received Date: 01/10/2018
• 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