MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 45/17; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number ARTHREX ECLIPSE HUMERAL HEAD, 45/17

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

Patient Problems Tissue Damage (2104); Osteolysis (2377)

Event Date 09/24/2019

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.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was discovered during social safeguard review that the following incident was mentioned in an arthrex chatter community: on (b)(6) 2019 a (b)(6) year old patient underwent a revision procedure where an arthrex eclipse ar-9345-17 (lot 1295172500) was explanted.The patient had a long surgical history involving this shoulder.Including an open glenohumeral operation that required his subscapularis being taken down.The subscap repair did not involve arthrex products and was reported to have failed.The arthrex eclipse device had been implanted during a 2018 procedure which was performed in kuwait.There is no additional information available with regard to the original arthrex implant procedure.During the (b)(6) 2019 procedure the arthrex eclipse device was found to be have a solid fixation in the patient bone.The device was able to be explanted with only the minimal bone loss equal to the space of the 18mm cage screw.During the procedure the cage screw, reunion and glenoid were also removed however there is no information available with regard to the part numbers of these devices.The devices will not be returning to arthrex for evaluation because they were reported to have been sent to pathology as specimen samples.

• Brand Name: ARTHREX ECLIPSE HUMERAL HEAD, 45/17
• Type of Device: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• 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: 9225661
• MDR Text Key: 165120234
• Report Number: 1220246-2019-01371
• Device Sequence Number: 1
• Product Code: QHQ
• UDI-Device Identifier: 00888867060029
• UDI-Public: 00888867060029
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/23/2019

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: ARTHREX ECLIPSE HUMERAL HEAD, 45/17
• Device Catalogue Number: AR-9345-17
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other