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

Catalog Number	317-3208
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	11/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient underwent a conversion of system approximately 3 months after primary surgery due to dislocation.This dislocation resulted from a progressive loosening of the glenoid baseplate after the primary surgery.No actual, implied, or suspected link to fx product.
Event or Problem Description
Revision was performed approximately 3 months after primary surgery for baseplate loosening and dislocation.No fall or other trauma noted.Revision was a conversion to hemi configuration as a result of dislocation.Primary surgery occurred (b)(6) 2023.32 mm centered glenosphere, 32 mm + 3 standard humeral cup, glenoid baseplate, and 32/8 reverse stem explanted.Replaced with 36/12 long stem, 48 mm offset head, and 24/10 eccentric taper adapter.

• Brand Name: HUMELOCK REVERSE
• 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: 18088291
• Report Number: 3014128390-2023-00040
• Device Sequence Number: 5884442
• Product Code: PHX
• UDI-Device Identifier: 03701037303696
• UDI-Public: 03701037303696
• 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): 11/07/2023

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: 317-3208
• Device Lot Number: T1592
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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: 102-0803 LOT: U0972; PART: 105-0029 LOT: T1305; PART: 105-3210 LOT: N2529
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female