MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS II HUMERAL STEM 9MM; SHOULDR PROSTH HEMI- HUM UNCEM

Model Number	UNIVERS II HUMERAL STEM 9MM
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Malfunction
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, the device fit with the humeral head returned and the taper lock was found to meet specifications.
Event or Problem Description
On (b)(6) 2021, it was reported by a sales representative via email that an ar-9100-09p humeral stem, an ar-9152-20p humeral head, and an ar-9100-07s univers apex humeral stem all failed to fit.This was discovered during a procedure on (b)(6) 2021.Surgeon completed case by using a larger stem.Additional information received 12/3/2021: this occurred during a total shoulder arthroplasty.

• Brand Name: UNIVERS II HUMERAL STEM 9MM
• Common Device Name: SHOULDR PROSTH HEMI- HUM UNCEM
• 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: 19219776
• Report Number: 1220246-2024-02657
• Device Sequence Number: 18192308
• Product Code: KWS
• UDI-Device Identifier: 00888867057104
• UDI-Public: 00888867057104
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/01/2024

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: 11/30/2025
• Device Model Number: UNIVERS II HUMERAL STEM 9MM
• Device Catalogue Number: AR-9100-09P
• Device Lot Number: 20.03423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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