MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS DALLAS FXV135 ANATOMICAL; SHOULDER PROSTHESIS

Catalog Number 105-0024

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 08/23/2023

Event Type  Injury  

Manufacturer Narrative

Patient dislocated and had a failure of implant integration after approximately two weeks during normal use.As the surgeon deemed the initial screws implanted as "too short", this is a user error during component selection during surgery.No actual, implied, or suspect link to fx product.

Event Description

Screws and construct failed during normal use approximately two weeks after implantation.Patient notes that they felt a pop (no pain reported), resulting in a dislocation.Screws from initial surgery deemed too short by the surgeon.Standard screws, fxv135 baseplate, 36 mm glenosphere, and 36 mm + 3 humeral cup explanted.Conversion to hemi.

• Brand Name: FXV135 ANATOMICAL
• Type of Device: 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: 17958334
• MDR Text Key: 325959719
• Report Number: 3014128390-2023-00029
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 03701037300237
• UDI-Public: 03701037300237
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 105-0024
• Device Lot Number: U0257
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PART: 105-3610 LOT: U0189; PART: 108-4520 LOT: T1780; PART: 108-4520 LOT: U0650; PART: 109-4520 LOT: S0060; PART: 109-4525 LOT: T0974; PART: 203-0803 LOT: T2041
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female