MAUDE Adverse Event Report: ARTHREX, INC. USP II HUMERAL HEAD 54/23; PROSTHESIS, SHOULDER, CEMENTED

Model Number	USP II HUMERAL HEAD 54/23
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the ar-9154-23p did not seat properly and could not be used.The surgeon used a new ar-9154-23p without further issue.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint not confirmed, no abnormality observed.The device was measured on a cmm and the taperlock met drawing specifications.

• Brand Name: USP II HUMERAL HEAD 54/23
• Common Device Name: PROSTHESIS, SHOULDER, CEMENTED
• 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: 19171706
• Report Number: 1220246-2024-02287
• Device Sequence Number: 7949718
• Product Code: KWS
• UDI-Device Identifier: 00888867057913
• UDI-Public: 00888867057913
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K071032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: USP II HUMERAL HEAD 54/23
• Device Catalogue Number: AR-9154-23P
• Device Lot Number: 12122757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• 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
• Patient Sex: Unknown