MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/15/2020
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 patient had undergone a reverse total shoulder arthroplasty, (b)(6) 2018.The patient was experiencing pain with shoulder pain from impingement.Ct/mri were performed by the original surgeon and a decision was made to perform a revision procedure, (b)(6) 2020.During the revision procedure the surgeon explanted the ar-9503s-03 (lot170137113) and ar-9504s-04 (lot 170147116).To complete the procedure the surgeon swapped an inferior glenosphere and put in a new poly the same size.The same surgeon performed both procedures.The same arthrex sales representative was present for both procedures.Per facility the devices will not be returned.

• Brand Name: HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10730284
• Report Number: 1220246-2020-02246
• Device Sequence Number: 3457317
• Product Code: PHX
• UDI-Device Identifier: 00888867061293
• UDI-Public: 00888867061293
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2020

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: 01/31/2023
• Device Model Number: HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP
• Device Catalogue Number: AR-9503S-03
• Device Lot Number: 170137113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 10/23/2020
• 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