MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE CAGE SCREW M, 35MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number AR-9301-02

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 02/15/2017

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.This is one of four submissions for the same event.The others are cc108390-line 186146-00091, cc108390-line 187581-00093 and cc108390-line 187584-00094.The device was received and an evaluation was conducted.Device history record review revealed nothing relevant to this event.The evaluation of the returned device revealed minor disrupted surface finish.The device's critical mating features are within specification.At this time, it cannot be determined how the device may have caused or contributed to the patient's experience.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.

Event Description

It was reported that patient had original eclipse surgery in 2013.Glenoid ar-9105-03, (lot 1230011) (cc108390 line 186146), screw-ar-9301-02, (lot 1127024) (cc108390 line 187579), trunion-ar-9300-49cpc, (lot 1128006) (cc180390 line 187581), humeral head- ar-9349-18, (lot 947018) (cc180390 line 187584) were implanted.Follow-up serial x rays showed increasing lucent lines around the pegged glenoid.Patient had pain and decision was made to revise to a revers per surgeon.Revision took place on (b)(6) 2017.The humeral component was removed without issue.Sales rep noted that the eclipse prosthesis was extremely well fixed and the cage screw had complete bone through growth.The glenoid was loose and was removed by hand with pegs intact.Cement was removed from the glenoid.Autograft was taken from the iliac crest to address the bone defect in the glenoid.The allograft was prepared for the revers base plate in situ prior to harvesting the graft.The baseplate was then tried to match the bone defect.The bone graft and base plate were implanted and fixated with the baseplate screws.The rest of the revers surgical technique was followed to complete the case.Patient was a (b)(6) male, dob (b)(6) 1938.The following information was obtained from patient medical records provided (b)(6) 2017: operative report (b)(6) 2013 surgery: date of original surgery was (b)(6) 2013.Hospital medical records (b)(6) 2017 through (b)(6) 2017: patient was originally scheduled to be discharged on (b)(6) 2017.Surgeon chose to extend one additional day.

• Brand Name: ECLIPSE CAGE SCREW M, 35MM
• 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: 6431854
• MDR Text Key: 70784250
• Report Number: 1220246-2017-00092
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/27/2017

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 Expiration Date: 06/01/2016
• Device Catalogue Number: AR-9301-02
• Device Lot Number: 1127024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 03/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• 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
• Patient Age: 79 YR