MAUDE Adverse Event Report: ARTHREX, INC. UNIVERSAL APEX HUMERAL STEM, 6 MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	AR-9100-06S
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/31/2017
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.This is one of three submissions for the same patient event.The others are 1220246-2017-00223 ((b)(4)) and 1220246-2017-00224 ((b)(4)).The evaluation revealed dents and scratches on the inclination block, stem, and trunnion.The damages observed on the surfaces were most likely caused during the extraction of the implant.The contribution of the device to the reported event could not be determined.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.
Event or Problem Description
It was reported that the patient underwent a right total shoulder arthroplasty procedure on (b)(6) 2014.In (b)(6) 2014, the patient began to experience laxity in the shoulder.On (b)(6) 2017, a revision revers total shoulder arthroplasty was performed where the previously implanted univers apex 6mm humeral stem (ar-9100-06s, lot: 974810, line 195553), small glenoid w/ peg (ar-9105-01, lot: 1329015, (b)(4)) and usp ii humeral head (ar-9144-17p, lot: 2501356510, (b)(4)) were explanted and replaced with arthrex revers total shoulder parts.

• Brand Name: UNIVERSAL APEX HUMERAL STEM, 6 MM
• 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: 6661143
• Report Number: 1220246-2017-00222
• Device Sequence Number: 750472
• Product Code: KWS
• UDI-Device Identifier: 00888867134416
• UDI-Public: 00888867134416
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K131633
• 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): 06/22/2017

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: 12/01/2018
• Device Catalogue Number: AR-9100-06S
• Device Lot Number: 974810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 06/22/2017
• 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