MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS APEX HUMERAL STEM, 8MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	UNIVERS APEX HUMERAL STEM, 8MM
Health Effect - Clinical Code	Rupture (2208)
Date of Event	06/23/2020
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 root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported, via the surgical outcome system, that a arthrex shoulder arthroplasty study patient (b)(6) was experiencing subscapularis failure.Upon further investigation the following information has been obtained: the patient had a primary procedure on (b)(6) 2016.During that procedure the following devices had been installed: ar-9100-08s humeral stem, ar-9144-19p humeral head and ar-9105-02 glenoid.The patient became symptomatic in early (b)(6) 2020 for subscapular and supraspinatus rupture.Ct scan findings confirmed rotator cuff tear on (b)(6) 2020.A revision reverse shoulder arthroplasty will be scheduled upon resolution of the current covid-19 pandemic.Additional information provided 6/2/20: revision surgery is scheduled to take place (b)(6) 2020.Additional information provided 6/26/20: it has been confirmed that the revision surgery took place on (b)(6) 2020 at the same facility and by the same surgeon as the original procedure.The original implants were explanted and the following devices were implanted during the revision: baseplate: ar-9560-24-2 155527.Central screw: ar-9561-30s 155541.Glenosphere: ar-9564-2436-lat 155566.Humeral stem: ar-9501-09p 145616.Suture cup: ar-9502f-36rcpc 139189.Humeral insert: ar-9503s-03 120148.Additional information provided 7/2/20: the sales rep reported they were unaware this case was a part of the study until the next day after the case was completed.The explanted implants are returning.
Additional Manufacturer Narrative
Complaint confirmed, the device was explanted during a revision surgery.No abnormality was found on the device that may have contributed to the reported event.

• Brand Name: UNIVERS APEX HUMERAL STEM, 8MM
• 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: 10279483
• Report Number: 1220246-2020-01952
• Device Sequence Number: 689915
• Product Code: KWS
• UDI-Device Identifier: 00888867134508
• UDI-Public: 00888867134508
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K131633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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 Model Number: UNIVERS APEX HUMERAL STEM, 8MM
• Device Catalogue Number: AR-9100-08S
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 07/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other