MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS REVERSED; UNCEMENTED SHOULDER PROTHESIS

Model Number	313-0706
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised on (b)(6) 2022 due to instability, approximately 1170 days after the first surgery.The surgeon explanted 1 humeral cup 36+6.The surgeon implanted 1 reversed adapter and 1 humeral cup 36+9.
Additional Manufacturer Narrative
This mdr has already been submitted to fda by the us importer with report number 3014128390-2022-00021.

• Brand Name: HUMERIS REVERSED
• Common Device Name: UNCEMENTED SHOULDER PROTHESIS
• 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: 15155495
• Report Number: 3009532798-2022-00120
• Device Sequence Number: 17459913
• Product Code: HSD
• UDI-Device Identifier: 03701037301364
• UDI-Public: 03701037301364
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 07/15/2022

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: 08/01/2022
• Device Model Number: 313-0706
• Device Catalogue Number: 313-0706
• Device Lot Number: L0588
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 08/03/2022
• 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