MAUDE Adverse Event Report: FX SOLUTIONS EASYTECH; METTALIC UNCEMENTED PROSTEHESIS SHOULDER

Model Number 112-0000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 11/04/2021

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 revisit on (b)(6) 2021 for infection.Approximately 15 days after the first surgery.The surgeon explanted double taper ta6v and centered head cro 46*17.The surgeon implanted centered head cro 46-17 and double taper ta6v.

• Brand Name: EASYTECH
• Type of Device: METTALIC UNCEMENTED PROSTEHESIS SHOULDER
• 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: 12873593
• MDR Text Key: 281268554
• Report Number: 3009532798-2021-00190
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 03701037300732
• UDI-Public: 03701037300732
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/22/2021

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 Model Number: 112-0000
• Device Catalogue Number: 112-0000
• Device Lot Number: P2366
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization