MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP; SHOULDR PROSTH, REVERSE CONFIG

Model Number	HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 11/13/2024, it was reported by a facility representative via email that arthrex devices were explanted from a patient.No additional information was provided.Additional information received on 11/25/2024: the patient underwent a total shoulder arthroplasty, rotator cuff repair, capsular release procedure on (b)(6) 2024.A 24mm glenoid univers revers baseplate, a 35mm central univers revers screw, a 5.5 x 28mm peripheral lock univers revers screw, a 5.5 x 32mm peripheral lock univers revers screw, a 5.5 x 16mm peripheral lock univers revers screw, a 5.5 x 16mm peripheral lock univers revers screw, a 24 x 39mm 4 lat taper univers revers glenosphere, a 39 2mm revers shoulder cup, a 14 apex univers revers stem, a 39 3 revers shoulder liner, and a 39 6mm revers shoulder humeral spacer were implant.Due to an injury the patient underwent revision surgery and had the 35mm central univers revers screw, the 5.5 x 28mm peripheral lock univers revers screw, and the 5.5 x 32mm peripheral lock univers revers screw removed.The revision surgery was completed without implanting any additional arthrex products.Both surgeries were performed by the same surgeons at the same facility.Additional information received on 12/6/2024: the revision surgery took place on (b)(6) 2024.The facility representative provided part numbers ar-9563-16, ar-9560-24, ar-9501-14s, ar-9564-2439-lat ar-9563-16, ar-9561-35s, and ar-9563-28, as the explanted products.
Additional Manufacturer Narrative
One unpackaged ar-9503m-03 arthrex univers revers humeral insert medium / 39 / +3 batch 19.02703 was received for evaluation.Visual evaluation of the humeral insert revealed gouges, dents, and deformation on the outside diameter and around the device area.It was concluded that the observed damage to the devices could most likely be attributed to the fact that they were implanted and then removed.Functional testing was not conducted because the damage to the device could prevent proper coupling with the returned ar-9502f-39rcpc or a known good device.The most likely cause of the reported failure is a patient-specific event.More specifically, according to the event description, the patient had to undergo revision surgery due to an injury unrelated to the device¿s functionality or performance.No allegation was identified against the ar-9503m-03 serial/batch number (b)(6); however, the returned device was damaged.

• Brand Name: HUMERAL INSERT M/39 +3 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: jared engle ; 8009337001
• MDR Report Key: 21400600
• Report Number: 1220246-2025-00464
• Device Sequence Number: 13141333
• Product Code: PHX
• UDI-Device Identifier: 00888867061255
• UDI-Public: (01)00888867061255(11)191220(17)241130(10)19.02703
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K142863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/17/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: HUMERAL INSERT M/39 +3 TO FIT IN 39 CUP
• Device Catalogue Number: AR-9503M-03
• Device Lot Number: 19.02703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2019
• 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