MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS II HUMERAL STEM 8MM; SHOULDR PROSTH HEMI- HUM UNCEM

Model Number UNIVERS II HUMERAL STEM 8MM

Device Problem Defective Device (2588)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/01/2023

Event Type  malfunction  

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.

Event Description

On (b)(6) 2023, it was reported by a sales representative via email that an ar-9100-08p univers ii humeral stem 8mm had an inclination screw locked in position when opened.The case was completed successfully by using a bigger size (9) primary stem.This was discovered during a reverse total shoulder procedure, with no patient harm.Additional information received on 4/05/2023: the locked inclination screw was discovered during implantation.The glenoid fracture was caused by screwing the glenosphere to the base plate.Additional information received on 4/5/2023: the faulty ar-9100-08p arthrex univers ii humeral stem 8mm was discovered prior to implantation.The surgeon had originally planned for an rsa procedure but due to a fracture of the glenoid while screwing in the ar-9560-24-2 baseplate and an ar-9564-2433-lat glenosphere.It was not caught until the glenosphere was inserted and the entire baseplate rotated and shifted.The surgeon proceeded by removing the glenosphere with a removal device and the baseplate was pulled out by hand.The case was completed using an ar-9100-09pc arthrex univers ii stem, size 9.Additional information received on 4/6/2023; the procedure was delayed 2 hours and additional anesthesia was administered to the patient.Even though a size 9mm stem was used to complete the case, the surgeon did not need to broach the canal larger.Instead, the ar-9100-09pc arthrex univers ii stem, size 9 was implanted slowly allowing the bone to expand before the final impaction.The surgeon is planning on a revision surgery but has not been scheduled yet.

• Brand Name: UNIVERS II HUMERAL STEM 8MM
• Type of Device: 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: vik bajnath ; 8009337001
• MDR Report Key: 16844966
• MDR Text Key: 314718596
• Report Number: 1220246-2023-06643
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867057081
• UDI-Public: 00888867057081
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/01/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: UNIVERS II HUMERAL STEM 8MM
• Device Catalogue Number: AR-9100-08P
• Device Lot Number: 19.02023
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/04/2023
• Initial Date FDA Received: 05/01/2023
• Date Device Manufactured: 11/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other