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

Model Number	DIAMETER 36 mm CENTERED
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/18/2021
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 due to infection that occured approximately 6 years after the primary surgery.The primary surgery used the humelock ii reversed system.During the revision surgery, the surgeon explanted the 135/145 ø36/+3 humeral cup and the ø36 centered glenosphere.Then, he implanted a 135/145 ø36/+9 humeral cup and a ø36 eccentric glenosphere.

• Brand Name: HUMELOCK II
• Common Device Name: REVERSED SHOULDER PROSTHESIS
• Manufacturer (Section D): FX SOLUTIONS; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 12554126
• Report Number: 3009532798-2021-00139
• Device Sequence Number: 1295588
• Product Code: PHX
• UDI-Device Identifier: 03701037300244
• UDI-Public: 03701037300244
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 09/30/2021

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: 02/28/2020
• Device Model Number: DIAMETER 36 mm CENTERED
• Device Catalogue Number: 105-3600
• Device Lot Number: I943
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/30/2021
• 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