MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 43/16; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number	ARTHREX ECLIPSE HUMERAL HEAD, 43/16
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Bacterial Infection (1735)
Date of Event	08/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint not confirmed.The device met all material specifications as received.Even though there was a complaint of an infection, no supporting lab results were given.The infection (if confirmed) would have come from something other than the implant based on the time period between initial surgery and revision.Arthrex¿s device is supplied sterile.As stated in the event, ¿the surgeon reports finding no issues with the devices at all.He did note that the glenoid was loose, most likely from chronic infection¿.
Event or Problem Description
It has been reported that a patient underwent an original surgery on (b)(6) 2014 and was part of an (b)(6) study program (study id number is (b)(6)).The surgeon has reported that the patient had a diagnosis of an infected contralateral shoulder replacement and two hip replacements that are infected.All components were explanted on (b)(6) 2019.At the same medical facility, with the same surgeon.In early 2019 the patient had developed an abscess.Exact date of onset of patient symptoms is unknown as the patient had been aspirated by another surgeon prior to his involvement in the issues resulting in the explant procedure.Surgeon saw the patient in (b)(6) of 2019 for the issues.Patient was scheduled for a radical debridement with antibiotic spacer at that time, however that procedure had to be cancelled due to medical reasons.Patient was admitted to the medical facility last week due to multiple joint infections and was cleared for the procedure to remove all components.An antibiotic spacer was implanted.The surgeon reports finding no issues with the devices at all.He did note that the glenoid was loose, most likely from chronic infection.Surgeon stated that the eclipse components were explanted only due to the infections and there was no complication with the device whatsoever.Cultures were sent, however results were not available.

• Brand Name: ARTHREX ECLIPSE HUMERAL HEAD, 43/16
• Common Device Name: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8930994
• Report Number: 1220246-2019-01276
• Device Sequence Number: 2206605
• Product Code: QHQ
• UDI-Device Identifier: 00888867060005
• UDI-Public: 00888867060005
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K183194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/26/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2014
• Device Model Number: ARTHREX ECLIPSE HUMERAL HEAD, 43/16
• Device Catalogue Number: AR-9343-16
• Device Lot Number: 0925602
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 08/26/2019
• 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