MAUDE Adverse Event Report: FX SHOULDER USA; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number 106-4600

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 02/12/2019

Event Type  Injury  

Event Description

The event was a revision of a shoulder surgery.The base plate and screws came out due to the patient's poor bone quality.During the revision surgery, the surgeon put a bigger head in and converted it to a hemi.

• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): FX SHOULDER USA; 13465 midway rd; suite 101; dallas TX 75244
• Manufacturer (Section G): FX SOLUTIONS; 1663 rue de majornas; viriat, rhone-alpes 01440 ; FR 01440
• Manufacturer Contact: samantha sterling ; 13465 midway rd; suite 101; dallas, TX 75244 ; 8002800775
• MDR Report Key: 8473170
• MDR Text Key: 140613073
• Report Number: 3014128390-2019-00002
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/01/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: 106-4600
• Device Lot Number: L1264
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/18/2019
• Initial Date FDA Received: 04/02/2019
• 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: 75 YR