MAUDE Adverse Event Report: FX SOLUTIONS EASYTECH; METALLIC UNCEMENTED PROSTHESIS SHOULDERS.

Catalog Number 106-4617

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 10/27/2021

Event Type  Injury  

Manufacturer Narrative

The event took place outside of the united states (in (b)(6)) and was associated with a product that is also cleared for the market within the united states.

Event Description

Patient was revised on (b)(6) 2021 due to cuff tear, approximately 7 years after the first surgery.The surgeon explanted centered head, double taper, anchor base, 2pegs glenoid.The surgeon implanted humeral cup standard 36+3, centered glenosphere, cementless glenoi base plante, post extension, stem size 10and screw.

• Brand Name: EASYTECH
• Type of Device: METALLIC UNCEMENTED PROSTHESIS SHOULDERS.
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• Manufacturer (Section G): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• Manufacturer Contact: ratsamy thevenin ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 12966808
• MDR Text Key: 281972633
• Report Number: 3009532798-2021-00178
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K111097
• 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: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 09/01/2018
• Device Catalogue Number: 106-4617
• Device Lot Number: E134
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2021
• 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
• Patient Age: 48 YR
• Patient Sex: Male