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

Catalog Number	103-0806
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Joint dislocation occurred with no known causal factors.No fall or trauma reported.No actual, implied, or suspect defect in fx product.
Event or Problem Description
Dislocation of shoulder approx.2 months after initial implantation.No fall or trauma reported.Standard humeral cup 36 mm + 6 swapped with stability humeral cup 36 mm + 3 and spacer + 9 mm.

• Brand Name: HUMELOCK REVERSED
• Common Device Name: REVERSE SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SHOULDER SOLUTIONS; 13465 midway rd; suite 100 & 101; dallas 75244
• Manufacturer (Section G): FX SHOULDER SOLUTIONS VIRIAT; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: tristan mahler ; 13465 midway rd; suite 100 & 101; dallas, TX 75244
• MDR Report Key: 17944791
• Report Number: 3014128390-2023-00025
• Device Sequence Number: 18053664
• Product Code: PHX
• UDI-Device Identifier: 03701037300107
• UDI-Public: 03701037300107
• 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: 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): 10/16/2023

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: 103-0806
• Device Lot Number: T0727
• 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: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male