MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS DALLAS HUMERIS REVERSED; REVERSE SHOULDER PROSTHESIS

Catalog Number 105-3600

Device Problem Premature Separation (4045)

Patient Problem Loss of Range of Motion (2032)

Event Date 01/22/2024

Event Type  Injury  

Event Description

Revision occurred approximately 6 years after the primary surgery, which occurred in (b)(6) 2018.The primary usage form was not able to be located, as the product was distributed through another vendor.No fall or other trauma reported.The cause for the revision was the glenosphere disassociating with the baseplate, seemingly over a long period of time.Surgeon notes indicate mobility and range of motion had been compromised.36 mm centered glenosphere and 36 mm + 6 standard humeral cup were explanted; the included part numbers are likely but not absolute as no primary usage form could be obtained.These parts were replaced with a 36 mm eccentric glenosphere, and 36 mm + 6 humeral stability cup.

Manufacturer Narrative

Revision occurred approximately 6 years after the primary implant.The glenosphere dissociated with the baseplate over a period of years.No actual, implied, or suspect link to fx product.

• Brand Name: HUMERIS REVERSED
• Type of Device: REVERSE SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SHOULDER SOLUTIONS DALLAS; 15920 addison road; addison TX 75001
• Manufacturer (Section G): FX SHOULDER SOLUTIONS DALLAS; 15920 addison road; addison TX 75001
• Manufacturer Contact: tristan mahler ; 15920 addison road; addison, TX 75001 ; 7137326920
• MDR Report Key: 18643926
• MDR Text Key: 334615426
• Report Number: 3014128390-2024-00007
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/05/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 105-3600
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/05/2024
• 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
• Treatment: PART: 203-0806 LOT: UNK
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female