MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, it was reported through the surgical outcome system that a revision surgery is required due to a complication and a loosening of an arthroplasty implant.The date of the primary procedure was on (b)(6) 2017 for a left reverse total shoulder replacement were an univers revers, glenosphere size (39mm), glenosphere offset (4mm lateral), stem fixation (pressfit), stem size (6), and suturecup (2mm posterior) was implanted.No additional information provided.Additional information requested.Additional information provided 1/20/2022: the complication was reported on (b)(6) 2018.The date of the revision procedure was (b)(6) 2018 for a rsa with cancellous allograft and an ar-9120-01 and an ar-9503m-06 was explanted.Device(s) were discarded.
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.

• Brand Name: HUMERAL INSERT M/39 +6 TO FIT IN 39 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: 13471406
• Report Number: 1220246-2022-04406
• Device Sequence Number: 13974362
• Product Code: PHX
• UDI-Device Identifier: 00888867061279
• UDI-Public: 00888867061279
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/07/2022

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 Model Number: HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP
• Device Catalogue Number: AR-9503M-06
• Device Lot Number: 120146
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 02/07/2022
• 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