MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS HUMERAL STEM, SIZE 6; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Model Number	UNIVERS REVERS HUMERAL STEM, SIZE 6
Health Effect - Clinical Codes	Fever (1858); Pain (1994); Rash (2033)
Date of Event	09/06/2018
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 therefore the complainant's event could not be verified.The device remains in the patient.The cause of the event could not be determined from the information available and without device evaluation.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Product directions for use warns of effects like foreign body and allergic-like reactions as well as infections both deep and superficial to the implant materials.Patient sensitivity to materials must be considered prior to implantation.
Event or Problem Description
It was reported by a nurse at an allergist's office that a patient had right shoulder-reverse total shoulder arthroplasty on (b)(6) 2017.During the surgery the following products (lot numbers unknown) were implanted in the patient: ar-9501-06p universal reverse humeral stem, ar-9502-36rcpc universal reverse cup, ar-9145-30 universal glenoid peripheral locking screw (qty unknown) and ar-9120-01 universal glenoid baseplate small.It has been reported that patient began having reaction type symptoms, low grade temperature - pain - rash, almost immediately after the procedure which has persisted.No cultures have been taken however blood work taken showed no infection indicated.Patient is being seen by an allergist to attempt to determine if patient may have an allergy to the arthrex implants.Material composition of the products has been provided to the reporter.

• Brand Name: UNIVERS REVERS HUMERAL STEM, SIZE 6
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7901906
• Report Number: 1220246-2018-00661
• Device Sequence Number: 182570
• Product Code: HSD
• UDI-Device Identifier: 00888867249264
• UDI-Public: 00888867249264
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/24/2018

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 Model Number: UNIVERS REVERS HUMERAL STEM, SIZE 6
• Device Catalogue Number: AR-9501-06P
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 09/24/2018
• 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