MAUDE Adverse Event Report: ARTHREX, INC. USP II HUMERAL HEAD 44/19; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	USP II HUMERAL HEAD 44/19
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/28/2018
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 initially reported via the surgical outcome alert system that a possible revision may have taken place with study patient (b)(6).Further investigation has now confirmed the following information: the study patient had a total shoulder arthroplasty (b)(6) 2018.Due to a rotator cuff/subluxation, deficient supraspinatus and subscapularis the patient underwent a revision surgery (b)(6) 2018 at the same facility by the same surgeon.During the revision surgery the following arthrex products were explanted: glenoid: ar-9106-02.Humeral stem: ar-9100-09s.Humeral head: ar-9144-19p.To complete the revision surgery the surgeon used and antibiotic wash after removal of the implants a bone allograft was used on the glenoid.Humeral canal was reamed and broached in 30 degrees of retroversion.

• Brand Name: USP II HUMERAL HEAD 44/19
• 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: 10483811
• Report Number: 1220246-2020-02127
• Device Sequence Number: 1246019
• Product Code: KWS
• UDI-Device Identifier: 00888867057708
• UDI-Public: 00888867057708
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K071032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/02/2020

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: USP II HUMERAL HEAD 44/19
• Device Catalogue Number: AR-9144-19P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/02/2020
• 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