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

Model Number	UNIVERS II HUMERAL STEM 6MM
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Swelling (2091); Discomfort (2330)
Date of Event	11/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The device was reported to have been discarded.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported via (b)(6) study program that the following arthrex parts were implanted on (b)(6) 2014: humeral stem: ar-9100-06p ¿ lot # 2501343611, humeral head: ar-9148-19p ¿ lot # 2501245007, keeled glenoid: ar-9104-02 ¿ lot # 2501416710.It was reported that after implantation, the patient (subject (b)(6)) complained of increased left shoulder pain when sleeping on left side.Patient was given an ultrasound guided acromioclavicular join injection on (b)(6) 2015.Patient was given a second injection on (b)(6) 2015.On (b)(6) 2016 patient noted slightly increased pain while pushing father in wheelchair.On (b)(6) 2016 patient underwent open distal clavicle resection.On (b)(6) 2016 patient was lifting their father off the ground after the father had fallen.The patient was experiencing increased pain over anterosuperior left shoulder at the incision site and ac joint.It was discovered that the patient had developed a hematoma.On (b)(6) 2016 patient called with increased pain.Patient had a "subachromial" cortisone injection to the left shoulder.Suspected rotator cuff pathology.Patient completed the study on (b)(6) 2016, but was still experiencing pain and discomfort.Ct results of left shoulder demonstrates full thickness subscapularis and supraspinatus tear grade 2.On (b)(6) 2016 subject underwent a reverse shoulder replacement.Additional information has been requested.Additional information received on 11/05/2018: it was confirmed by the sr.Clinical research associate that all arthrex parts that were originally implanted during the (b)(6) "204" procedure were explanted on (b)(6) 2016 at the same facility, and by the same surgeon that performed the original surgery.The original procedure performed was a total shoulder arthroplasty procedure.It was reported that an arthrex sales representative was not present during the revision surgery that took place on (b)(6) 2016.The clinical research associate stated that the devices were explanted due to soft-tissue failure.It was reported that the patient first started experiencing pain and discomfort on (b)(6) 2015.The pain that the patient was experiencing was resolved due to the open distal clavicle resection that the patient had on (b)(6) 2016.However, new pain was reported on (b)(6) 2016 due to the patient lifting their father off of the ground.This caused acute swelling over the ac joint and increased pain.
Additional Manufacturer Narrative
This is a follow-up submission to update the occurrence date/event date that was not updated at the time the revision surgery date was received and was not done in the initial submission.The correct occurrence date/event date is 11/17/2016 and not 10/23/14.The awareness date stayed the same as it was in the initial submission.

• Brand Name: UNIVERS II HUMERAL STEM 6MM
• 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: 8083813
• Report Number: 1220246-2018-00751
• Device Sequence Number: 13515874
• Product Code: KWS
• UDI-Device Identifier: 00888867057050
• UDI-Public: 00888867057050
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K010124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

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: 10/31/2018
• Device Model Number: UNIVERS II HUMERAL STEM 6MM
• Device Catalogue Number: AR-9100-06P
• Device Lot Number: 2501343611
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 03/01/2019
• 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