MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 47/18; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number	ARTHREX ECLIPSE HUMERAL HEAD, 47/18
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that a revision shoulder surgery was performed on (b)(6) 2020.The glenoid got loose post op.No further information provided by the customer.The device will not return for investigation.Update 05-mar-2020: further information was provided that the initial surgery was performed on (b)(6) 2014.Update 06-aug-2020: further information were provided that the following devices were also explanted during the initial revision surgery.Ar-9347-18 batch 1295131706.Ar-9300-47cpc batch12.744.Ar-9301-02 batch 13.389.
Additional Manufacturer Narrative
Complaint not confirmed, no abnormality was observed on the device that may have contributed to the event.

• Brand Name: ARTHREX ECLIPSE HUMERAL HEAD, 47/18
• Common Device Name: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10431422
• Report Number: 1220246-2020-02069
• Device Sequence Number: 3447243
• Product Code: QHQ
• UDI-Device Identifier: 00888867060043
• UDI-Public: 00888867060043
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K183194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2020

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: 10/31/2018
• Device Model Number: ARTHREX ECLIPSE HUMERAL HEAD, 47/18
• Device Catalogue Number: AR-9347-18
• Device Lot Number: 1295131706
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 09/09/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other