MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP; SHOULDR PROSTH, REVERSE CONFIG

Model Number	HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 06/16/2023, it was reported by a sales representative via sems that an ar-9512 stem/cup extraction adapter handle was stripped, and an ar-1999hh ratcheting handle broke.This occurred during an reverse total shoulder arthroplasty revision case on (b)(6) 2023, while taking the suture-cup out of the ar-9512 it stripped and could not twist into the suture-cup.While taking the baseplate out the ar-1999hh broke and did not ratchet appropriately.Another of the same part was used to continue.The case carried on and was completed successfully.There was no additional information provided, additional information has been requested.Additional information was provided on 06/26/2023, it was reported that on (b)(6) 2021 the patient underwent a reverse total shoulder arthroplasty procedure in which ar-9502f-42rcpc suture cup, an ar-9503l-03c humeral insert, and an ar-9550-09 univers revers¿ spacer were implanted.On 06/15/2023 the patient underwent a reverse total shoulder arthroplasty revision procedure where the ar-9502f-39rcpc, and ar-9503m-06 were explanted.The case was completed using other parts.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP
• Common Device Name: SHOULDR PROSTH, REVERSE CONFIG
• 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: emily shafer ; 8009337001
• MDR Report Key: 17273044
• Report Number: 1220246-2023-07083
• Device Sequence Number: 14348732
• Product Code: PHX
• UDI-Device Identifier: 00888867061279
• UDI-Public: 00888867061279
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: HUMERAL INSERT M/39 +6 TO FIT IN 39 CUP
• Device Catalogue Number: AR-9503M-06
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown