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

Model Number	CEMENTED Ø40/10
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event took place outside of the united states ((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 due to dislocation approximately 1 month after the primary surgery.The primar surgery used the humelock reversed system.During he revision surgery, the surgeon explanted the size 10 cemented stem, the +9mm humeral spacer and the ø36/+6 standard humeral cup.Then he implanted a size 12 cementless stem, a ø36/+9 standard humeral cup and a new +9mm humeral spacer.Clinical case of retrospective study.

• Brand Name: HUMELOCK REVERSED
• Common Device Name: REVERSE SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 11892147
• Report Number: 3009532798-2021-00052
• Device Sequence Number: 3686009
• Product Code: PHX
• UDI-Device Identifier: 03701037301449
• UDI-Public: 03701037301449
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K162455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2021

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: 03/30/2020
• Device Model Number: CEMENTED Ø40/10
• Device Catalogue Number: 313-4010
• Device Lot Number: I643
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 05/27/2021
• 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