MAUDE Adverse Event Report: FX SOLUTIONS HUMERUS ANATOMIC; METALIC UNCEMENTED SHOULDER PROSTHESIS

Model Number	400-1101
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This mdr has already been submitted to fda by the us importer with report number (b)(4).
Event or Problem Description
The patient was revised on (b)(6) 2021 due to rotator cuff failure.Approximately 1 years after first surgery.The surgeon explanted 1 pegs glenoid (xs), 1 offset head cocr (41/16), 1 double taper (0) and 1 humeris stem (08).The surgeon implanted 1 glenoid baseplate (24mm), 1 centered glenosphere (36mm), 1 humeral cup (36/+3), 1 post extension, 2 locking screw and 1 standard screw.

• Brand Name: HUMERUS ANATOMIC
• Common Device Name: METALIC UNCEMENTED 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: 13657940
• Report Number: 3009532798-2021-00267
• Device Sequence Number: 5110983
• Product Code: HSD
• UDI-Device Identifier: 03701037301692
• UDI-Public: 03701037301692
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K163669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 01/24/2022

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: 01/05/2023
• Device Model Number: 400-1101
• Device Catalogue Number: 400-1101
• Device Lot Number: M0956
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 03/03/2022
• 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