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

Catalog Number	115-3610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Dislocation occurred approximately 3 months after initial implantation.No pain or trauma reported.Glenoid baseplate, 36 mm glenosphere, 36 mm + 6 standard humeral cup, cementless post extension, and four screws explanted.Replaced with offset head and 24 mm taper adapter.
Additional Manufacturer Narrative
Dislocation occurred approximately 3 months after initial implantion 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: 17966219
• Report Number: 3014128390-2023-00033
• Device Sequence Number: 20750615
• Product Code: PHX
• UDI-Device Identifier: 03701037300800
• UDI-Public: 03701037300800
• 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): 10/19/2023

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: 115-3610
• Device Lot Number: T1522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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: 103-0806 LOT: T1118.; PART: 105-0006 LOT: T2372.; PART: 105-0024 LOT: U0079.; PART: 107-4530 LOT: S1844.; PART: 108-4520 LOT: T1607.; PART: 108-4525 LOT: T1611.; PART: 108-4530 LOT: T1278.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Unknown