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

Model Number	316-0016
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/13/2021
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, approximately 4 months after the primary surgery on (b)(6) 2021 due to failure in the repair of the rotator cuff.A humeris stem cementless (16), double taper, 3-4 pegs glenoid and cocr head (50x20) were explanted.A glenoid baseplate (24), centered glenosphere (40/10) and post extension cementless (6) were implanted.

• Brand Name: HUMERIS ANATOMIC
• Common Device Name: METALLIC UNCEMENTED PROSTHESIS 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: 13385165
• Report Number: 3009532798-2021-00257
• Device Sequence Number: 4779500
• Product Code: HSD
• UDI-Device Identifier: 03701037303689
• UDI-Public: 03701037303689
• 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: 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): 01/10/2022

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: 10/01/2024
• Device Model Number: 316-0016
• Device Catalogue Number: 316-0016
• Device Lot Number: N1575
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 01/28/2022
• 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