MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ECLIPSE HUMERAL HEAD, 39/18; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number	ARTHREX ECLIPSE HUMERAL HEAD, 39/18
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	05/15/2020
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
An arthrex employee has reported that after 1 year and 7 month after initial surgery a revision surgery took place.According to surgeon the rotator cuff was irreparable and therefore it was changed from an anatomic to an inverse prothesis.The eclipse had settled in well and showed no sign of loosening.The glenoid was not supplied with the eclipse when it was fitted.The supply with a univers revers went very well.Update 25-may-2020: further information provided that the revision was needed as the patient suffered pain and was not able to rise the arm anymore.No further information is available as to how the devices contributed to the reported event.

• Brand Name: ARTHREX ECLIPSE HUMERAL HEAD, 39/18
• Common Device Name: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10114053
• Report Number: 1220246-2020-01874
• Device Sequence Number: 11671767
• Product Code: QHQ
• UDI-Device Identifier: 00888867059979
• UDI-Public: 00888867059979
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2020

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: 08/31/2022
• Device Model Number: ARTHREX ECLIPSE HUMERAL HEAD, 39/18
• Device Catalogue Number: AR-9339-18
• Device Lot Number: 1738006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 06/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other