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

Catalog Number	317-4014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision occurred on or around (b)(6) 2024.The primary surgery occurred in the last 12-15 months, and was a reverse system implanted due to arthritis.There was not enough information provided to determine with any degree of certainty which fx line the system was, or which surgeon performed the initial implantation.Revision occurred due to a reaction to the implants not related to an infection, as confirmed by culture swab.According to the surgeon, the symptoms were consistent with metallosis or an allergy to the metal components of the system.Within a month of the primary surgery, the patient was having aspirations performed on the implant site every 2-3 weeks to control inflammation.Upon explantation, the system was seen to have been heavily worn in a manner consistent with metallosis.The system was replaced by an anti-biotic spacer, as the patient wishes to weigh options on all systems available before replacement.No further information was provided by the representative after three attempts to gather such information.
Additional Manufacturer Narrative
Revision occurred after 12-15 months for metallosis or other reaction to the implants that was not related to an infection.No actual, implied, or suspect link to fx product.
Event or Problem Description
This report is a follow up to per 24-602 / mdr 3014128390-2024-00046.Any discrepancies between this corrected account and the prior report are attributed to the patient's extreme reluctance to share information.Revision occurred on (b)(6) 2024, approximately 5 years after the prior revision surgery which occurred on (b)(6) 2019; this surgery was a poly swap for infection and concerns of aspiration.The primary surgery occurred on (b)(6) 2017.No fall or other trauma reported.Revision was a total explantation of all fx product, following a lengthy regimen of effusions to treat atypical metallosis, detailed below.40/14 system stem, 24 mm cementless glenoid baseplate, 40 mm centered glenosphere, 40 mm + 6 humeral standard cup, and 9 mm humeral spacer explanted.These parts were replaced with an antibiotic spacer.Patient was drained of fluid at the implant site once every 2-4 weeks for "several years", potentially as far back as the primary surgery, although the 2019 revision is the 1st record of metallosis for the patient from available data.On (b)(6) 2024, the patient underwent another surgery to replace the antibiotic spacer; there was no fx product in the patient at this time.The surgeon noted that extreme metallosis was present, with black debris present throughout the joint and extending into the pectoral muscle and posterior forearm.This surgery also yielded the first definitive positive for infection.Every other revision surgery the patient underwent, including the surgery for removal of fx product, did not yield a positive infection culture.The reporter notes that due to a series of chronic dislocations, the patient's glenoid area is severely compromised.No definitive dates are given for when the dislocations occurred, or for any surgical intervention which did not involve explantation of fx product.Any determination of root cause of the dislocations would be speculative, but the repeated fluid build-up is certainly a factor.Patient has elected not to answer any follow-up questions and requests for surgical notes made through the various medical professionals involved.
Additional Manufacturer Narrative
Revision occurred after 5 years for metallosis or other reaction to implants that was not related to an infection.No actual, implied, or suspect link to fx product.

• Brand Name: HUMELOCK 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: 20240609
• Report Number: 3014128390-2024-00046
• Device Sequence Number: 18302228
• Product Code: PHX
• UDI-Device Identifier: 03701037303788
• UDI-Public: 03701037303788
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K162455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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 Expiration Date: 06/01/2022
• Device Catalogue Number: 317-4014
• Device Lot Number: L0228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2017
• 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: 103-0007 LOT: M1511; PART: 104-0806 LOT: L2843; PART: 105-0024 LOT: L0157; PART: 105-4010 LOT: L1235; PART: 108-4520 LOT: 0270; PART: 108-4520 LOT: K521; PART: 108-4525 LOT: 0320
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male