MAUDE Adverse Event Report: ARTHREX, INC.; TOT ANAT SHOULDR PROSTH, UNCEM

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2022

Event Type  Injury  

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 1/16/2024, it was reported by a sales representative via email that an ar-9580-2410s univers revers modular glenoid system augmented baseplate became loose post-operative.In (b)(6) of 2022, the patient underwent an augmented rtsa procedure in which the baseplate was implanted.The baseplate became loose, and the patient underwent revision surgery on (b)(6) 2024.During the procedure, the baseplate was removed, and a new one was implanted with a screw more inferior.There was enough screw purchase, and the surgeon was pleased with the fixation.The stem was stable.Cultures were taken, and no infection was present.Additional information requested.

• Brand Name: UNK
• Type of Device: TOT ANAT SHOULDR PROSTH, 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: 18667002
• MDR Text Key: 334844649
• Report Number: 1220246-2024-00847
• Device Sequence Number: 1
• Product Code: QHQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: No
• 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