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

Catalog Number	115-3610
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision occurred approx.8 months after primary surgery due to patient pain; primary surgery occurred on (b)(6) 2023.No fall or other trauma noted.36 mm centered glenosphere and 36 mm + 6 standard humeral cup explanted.These parts were replaced with a 32 mm centered glenosphere, 9 mm spacer, 32 mm + 3 humeral cup, and a locking screw.
Additional Manufacturer Narrative
Revision occured 8 months after primary surgery due to patient pain.No actual, implied, or suspect link to fx product.

• Brand Name: FXV135 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: 18066446
• Report Number: 3014128390-2023-00039
• Device Sequence Number: 7615397
• 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): 11/03/2023

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: T1345
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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: 103-0806 LOT: N0268
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Unknown