MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS ANATOMIC; CEMENTED SHOULDER PROSTHESIS

Model Number	105-0004
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised on (b)(6) 2022 due to instability.Approximately 5 months after the last surgery.The surgeon explanted 1 double taper (0), 1 2 pegs glenoid (l) and 1 offset head (50x20).The surgeon implanted 1 glenoid baseplate (24), 1 central screw (12), 2 standard screw (25), 2 locking screw (20, 15), 1 centered glenosphere (40) and 1 humeral cup (40/3).
Additional Manufacturer Narrative
This mdr has already been submitted to fda by the us importer with report number (b)(4).

• Brand Name: HUMERIS ANATOMIC
• Common Device Name: CEMENTED SHOULDER PROSTHESIS
• 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: 13993200
• Report Number: 3009532798-2022-00077
• Device Sequence Number: 5230134
• Product Code: KWT
• UDI-Device Identifier: 03701037300190
• UDI-Public: 03701037300190
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2022

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: 01/06/2023
• Device Model Number: 105-0004
• Device Catalogue Number: 105-0004
• Device Lot Number: M2015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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