MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	09/18/2018
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 device was reported to have been discarded.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the patient required a revision of a reverse total shoulder due to dislocating.This was found during a post-op visit.The ar-9503m-03 was removed and replaced with ar-9503m-06c.Additional information obtained at time of initial report: original surgery was a subscap tendon repair on (b)(6) 2018.Due to tendon be damaged again a reverse total shoulder revision was performed on (b)(6) 2018.Explanted device was discarded by facility.Additional information is being requested.Additional information obtained 9/18/2018: on (b)(6) 2018 the patient received a reverse total shoulder procedure.At that time after everything was implanted the surgeon performed a subscap repair with #5 ethibond.Patient had a follow up visit on (b)(6) 2018 and patient stated that he had dislocated again.X-rays were taken and everything appeared normal.X-rays have been provided to arthrex from the post op visit where patient stated he had dislocated.Patient stated he had no fall or trauma before the follow up visit that lead to the dislocation.Upon opening the patient during the (b)(6) 2018 revision it was determined that the subscap repair that was done on the original procedure had failed.The sutures had been broken.During the revision surgeon trialed constrained liners since the subscap repair had failed and wasn't able to be repaired again.Surgeon felt the constrained liner would provide more stability than the original liner that had been used in the (b)(6) 2018 procedure.Patient was a male and the procedures were on his right shoulder.

• Brand Name: HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7943773
• Report Number: 1220246-2018-00697
• Device Sequence Number: 13685688
• Product Code: PHX
• UDI-Device Identifier: 00888867061255
• UDI-Public: 00888867061255
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/08/2018

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: 11/30/2022
• Device Model Number: HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP
• Device Catalogue Number: AR-9503M-03
• Device Lot Number: 170091511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/08/2018
• 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