MAUDE Adverse Event Report: ARTHREX, INC. MODULAR POST, 25MM; SHOULDR PROSTH, REVERSE CONFIG

Model Number	MODULAR POST, 25MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 5/10/2023, it was reported by a sales representative via email that an ar-9580-2420-2 baseplate was loosened post-operative.In (b)(6) of 2023, the patient reported an ongoing painful shoulder, and radiographs revealed the loosened baseplate with a post-migrating superior posterior of the glenoid.A revision surgery took place on (b)(6) 2023 to remove the devices implanted during the original procedure on (b)(6) 2021.During the revision of shoulder arthroplasty, an ar-9580-2420-2 baseplate, an ar-9582-25 modular post, an ar-9563-16 ar-9563-16, an ar-9563-24 peripheral screw, an ar-9562-28nl peripheral screw, an ar-9562-24nl peripheral screw, and an ar-9564-2439-lat glenosphere were successfully removed.Both procedures were performed at the same facility and by the same surgeon.Additional information received on 5/11/2023: the revision surgery was completed by implanting an ar-9503m-03 humeral insert m/39 +3 to fit in 39 cup , an ar-9505-09 univers revers spacer 39+9mm, an ar-9563-32 5.5x32mm peripheral screw, locking, an ar-9564-2839 39/28 glenosphere, an ar-9560-28 28mm baseplate, modular, an ar-9562-24nl 4.5x24mm peripheral screw, non-locking, and ar-9563-20 5.5x20mm peripheral screw, locking, an ar-9562-36nl 4.5x36mm peripheral screw, non-locking, and an ar-9561-35p 35mm central post, modular.
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the customer-provided photos.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: MODULAR POST, 25MM
• 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: 17054629
• Report Number: 1220246-2023-06836
• Device Sequence Number: 19702922
• Product Code: PHX
• UDI-Device Identifier: 00888867341845
• UDI-Public: 00888867341845
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K193372
• 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): 10/16/2024

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: 05/31/2026
• Device Model Number: MODULAR POST, 25MM
• Device Catalogue Number: AR-9582-25
• Device Lot Number: 1032262102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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