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

Catalog Number	115-3613
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Dislocation of glenosphere after approximately 5 months due to joint instability.Pain reported.36 mm eccentric glenosphere and 36 mm + 3 standard humeral cup explanted.Replaced with 36 mm eccentric glenosphere and 36 mm + 3 standard humeral cup explanted.
Additional Manufacturer Narrative
Patient dislocation approximately 5 months after initial implantation of device with no known cause.No actual, implied, or suspect link to fx product.

• 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: 17975249
• Report Number: 3014128390-2023-00035
• Device Sequence Number: 16770585
• Product Code: PHX
• UDI-Device Identifier: 03701037300817
• UDI-Public: 3701037300817
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191146
• 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): 10/20/2023

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: 115-3613
• Device Lot Number: S0817
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2022
• 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: 103-0803 LOT: T0956
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male