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

Model Number	112-0000
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3009532798-2021-00190
• Device Sequence Number: 17270528
• Product Code: HSD
• UDI-Device Identifier: 03701037300732
• UDI-Public: 03701037300732
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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 Expiration Date: 07/01/2026
• Device Model Number: 112-0000
• Device Catalogue Number: 112-0000
• Device Lot Number: P2366
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 11/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown