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

Model Number	Size 12 Cementless
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event took place outside of the united states (in (b)(6)) and was associated with a product that is also cleared for the market within the united states.
Event or Problem Description
The event was a revision surgery.The reason of the revision is unknown.The primary surgery used the humelock ii reversed system.The surgeon explanted all the components of the reverse total shoulder arthroplasty.No components were implanted.He explanted the ø40 eccentric glenosphere, the ø40/+9 standard humeral cup, the ø24 baseplate, the size 12 cementless stem and associated screws.

• Brand Name: HUMELOCK II REVERSED
• Common Device Name: REVERSED SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 12279195
• Report Number: 3009532798-2021-00114
• Device Sequence Number: 14602412
• Product Code: PHX
• UDI-Device Identifier: 03701037301067
• UDI-Public: 03701037301067
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K130759
• 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
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2021

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: 03/01/2026
• Device Model Number: Size 12 Cementless
• Device Catalogue Number: 311-0212
• Device Lot Number: P1392
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention