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

Catalog Number	317-3614
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient was revised 1 month after primary surgery due to lack of following surgical technique during primary surgery.No actual, implied, or suspect link to fx product.
Event or Problem Description
Revision was performed approximately 1 month after the primary surgery; primary surgery occurred on (b)(6) 2023.No fall or other trauma noted.Patient presented with a loosened stem within the humeral canal.36x14 stem, 40 mm +3 stability humeral cup, and 9 mm spacer explanted.These parts were replaced with a 40x14 stem, 40 mm + 3 stability humeral cup, 9 mm spacer, a 34 mm cortical screw, and a 28 mm cortical screw.The primary surgery was treatment for a fracture.Contrary to the surgical technique for the primary surgery, the surgeon did not include any distal screws, which allowed the stem to loosen.Surgeon stated that all future proximal humeral fractures will be treated with distal screws.

• Brand Name: HUMELOCK REVERSED
• Common Device Name: REVERSE SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SHOULDER SOLUTIONS DALLAS; 13465 midway rd; suite 100 & 101; dallas TX 75244
• Manufacturer (Section G): FX SHOULDER SOLUTIONS DALLAS; 13465 midway rd; suite 100 & 101; dallas TX 75244
• Manufacturer Contact: tristan mahler ; 13465 midway rd; suite 100 & 101; dallas, TX 75244 ; 7137326920
• MDR Report Key: 18187434
• Report Number: 3014128390-2023-00042
• Device Sequence Number: 6663000
• Product Code: PHX
• UDI-Device Identifier: 03701037303757
• UDI-Public: 03701037303757
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 11/21/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 317-3614
• Device Lot Number: S0698
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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: P1280; PART: 104-1003 LOT: P0821
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male