MAUDE Adverse Event Report: ARTHREX, INC. UNI GLENOID-PERIPHERAL LOCK SCRW; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number UNI GLENOID-PERIPHERAL LOCK SCRW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Pain (1994); Rash (2033)

Event Date 09/06/2018

Event Type  Injury  

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 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: UNI GLENOID-PERIPHERAL LOCK SCRW
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 7901945
• MDR Text Key: 121475884
• Report Number: 1220246-2018-00663
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867057722
• UDI-Public: 00888867057722
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: UNI GLENOID-PERIPHERAL LOCK SCRW
• Device Catalogue Number: AR-9145-30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 09/24/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other