MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS APEX HUMERAL STEM, 6MM; PROSTHESIS, SHOULDER, CEMENTED

Model Number	UNIVERS APEX HUMERAL STEM, 6MM
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a tsa procedure yesterday the ar-9100-06s 6mm apex stem was faulty.The inclination adjustment on the stem would not free adjust even when the inferior screw was loosened.The case was completed without further issue by using a second stem.The rep examined the faulty stem after the procedure and it was clear that the stem is frozen at full inclination.See attached image.
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 ar-9100-06s received was evaluated by engineering.The inclination block moved freely once the set screw was loosened.

• Brand Name: UNIVERS APEX HUMERAL STEM, 6MM
• 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: 19172480
• Report Number: 1220246-2024-02304
• Device Sequence Number: 15417887
• Product Code: KWS
• UDI-Device Identifier: 00888867134416
• UDI-Public: 00888867134416
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K024291
• 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 Model Number: UNIVERS APEX HUMERAL STEM, 6MM
• Device Catalogue Number: AR-9100-06S
• Device Lot Number: 10364398
• 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: 05/06/2021
• Initial Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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