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

Catalog Number	105-3600
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	01/22/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3014128390-2024-00007
• Device Sequence Number: 7129108
• Product Code: PHX
• UDI-Device Identifier: 03701037300244
• UDI-Public: 03701037300244
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K150488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 105-3600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PART: 203-0806 LOT: UNK
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female