MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK REVERSED; REVERSED SHOULDER PROSTHESIS

Catalog Number 317-3614

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 12/04/2019

Event Type  Injury  

Event Description

Patient underwent second revision surgery on (b)(6) 2019, due to infection.All manufacturer's products were explanted, including size 14 humelock reversed stem, +9mm humeral spacer, 36/+6 humeral cup, 24mm glenoid baseplate, 36mm centered glenosphere with screw, and all screws.Surgeon then implanted antibiotic spacer from another manufacturer to help with infection.First revision to revise humeral components occurred when patient dislocated in recovery room on (b)(6) 2019 and has been previously reported to fda.

• Brand Name: HUMELOCK REVERSED
• Type of Device: REVERSED SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SOLUTIONS; 1663 rue de majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: samantha sterling ; 13465 midway rd; suite 101; dallas, TX 75244 ; 2148904109
• MDR Report Key: 9526416
• MDR Text Key: 174408067
• Report Number: 3014128390-2019-00078
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Catalogue Number: 317-3614
• Device Lot Number: M1114
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR