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

Catalog Number	105-0024
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3014128390-2023-00029
• Device Sequence Number: 14772855
• Product Code: KWT
• UDI-Device Identifier: 03701037300237
• UDI-Public: 03701037300237
• 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): 10/18/2023

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: 105-0024
• Device Lot Number: U0257
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2023
• 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: 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female