MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE TRUNION, 45 MM TPS CTD; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number AR-9300-45CPC

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Purulent Discharge (1812); Foreign Body Reaction (1868)

Event Date 05/23/2017

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.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 cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.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.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.This is one of four submissions for the same patient event.The others are 1220246-2017-00226 ((b)(4)), 1220246-2017-00228 ((b)(4)) and 1220246-2017-00229 ((b)(4)).Device reported to have been discarded.

Event Description

It was reported that the patient received an eclipse implant into the left shoulder with the following devices used during procedure: ar-9345-17, lot 1611019 ((b)(4)); ar-9300-45cpc, lot 150083212((b)(4)); ar-9301-02, lot 150073614 ((b)(4)); and ar-1928sf-3, lot 10020391 ((b)(4)); along with a non arthrex glenoid.The implants got dislocated due to a tendon that did not adhere it.The decision was made to revise it with a reverse implant in 2017.During the revision surgery when the shoulder was opened the surgeon found pus and the eclipse implants were loose in the joint.Pathological investigation did not find any lab culture but a foreign body reaction /allergic reaction was diagnosed.Additional information received on 13 jun 2017: information received that the complaint devices will not be returned as they were discarded at the facility.Date of the initial surgery was on (b)(6) 2017, date of second surgery/revision was on (b)(6) 2017.

• Brand Name: ECLIPSE TRUNION, 45 MM TPS CTD
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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, sr mdr analyst ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 6672689
• MDR Text Key: 78555059
• Report Number: 1220246-2017-00227
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Catalogue Number: AR-9300-45CPC
• Device Lot Number: 150083212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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