MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK II; REVERSED SHOULDER PROTHESIS

Catalog Number	106-4300
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was revised for reduced mobility on (b)(6) 2023, resulting from the deterioration of the rotator cuff following non-compliance with installation techniques (ascension of the stem not locked by the operator).The implantation date was on (b)(6) 2023.An offset head and a double taper were explanted.A cup, a glenosphere, a metaglene and screws were implanted.
Additional Manufacturer Narrative
The event took place outside the united states (in france) and was associated with a product that is also cleared for the market in the united states.

• Brand Name: HUMELOCK II
• Common Device Name: REVERSED 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: emeric obin ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 18370729
• Report Number: 3009532798-2023-00129
• Device Sequence Number: 7601205
• Product Code: PHX
• UDI-Device Identifier: 03701037300480
• UDI-Public: 03701037300480
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2024
• Device Catalogue Number: 106-4300
• Device Lot Number: N0409
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 12/21/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown