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	Fall (1848)
Date of Event	11/05/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via phone that an ar-9564-2436-lat glenosphere (line #1) and an ar-9503s-03 humeral cup (line #2) were explanted on (b)(6) 2021 due to a dislocation, caused by a fall.The date of the primary procedure was on (b)(6) 2021 and took place at (b)(6) rehabilitation and orthopedic institute, arthrex account #(b)(6).The ar-9564-2439-lat glenoshpere, ar-9503-3639-3c combo humeral insert, and ar-9555-09 spacer, were implanted during the reported revision surgery.The ar-9503-3639-6c humeral insert was implanted then explanted as the device was the incorrect size.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12853692
• Report Number: 1220246-2021-03985
• Device Sequence Number: 14604564
• 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: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/22/2021

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: 06/30/2025
• Device Model Number: HUMERAL INSERT S/36 +3 TO FIT IN 36 CUP
• Device Catalogue Number: AR-9503S-03
• Device Lot Number: 20.00988
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 11/22/2021
• Date Device Manufactured: 07/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown