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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ar-9100-06s univers apex humeral stem implant was inserted as per the technique.The threads would not properly "seat" the implant for proper positioning.A second implant was used and inserted in the proper position.No additional time or adverse action was needed.
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 confirmed.One unpackaged ar-9100-06s, batch 10321777 humeral stem was received for investigation.Visual inspection noted that the version locking screw was seated within the trunion, and the inclination locking screw was not returned for analysis.Attempts at functional testing identified that the version locking screw could not be removed from the trunion, indication potential thread damage.No other abnormalities were observed.As neither the inner diameter of the trunion nor the version locking screw threading were able to be assessed.A potential most probable cause can be attributed to over-engaging the screw within the trunion.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation.

• 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: 19519059
• Report Number: 1220246-2024-05605
• Device Sequence Number: 8412683
• Product Code: KWS
• UDI-Device Identifier: 00888867134416
• UDI-Public: 00888867134416
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K131633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

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: 10321777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 06/12/2024
• 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