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

Model Number 311-0212

Device Problem Microbial Contamination of Device (2303)

Event Date 12/14/2022

Event Type  Injury  

Manufacturer Narrative

The event took place outside the united stated (in france) and was associated with a product that is also cleared for the market in the united states.

Event Description

The patient was revised due to a revision for infection on (b)(6) 2022.The implantation date was on (b)(6) 2022 (date unknown).A cup, a glenosphere, a metaglene and a stem were explanted.No implant was implanted.

• Brand Name: HUMELOCK II REVERSED
• Type of Device: 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: ratsamy thevenin ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 16146789
• MDR Text Key: 307178371
• Report Number: 3009532798-2023-00002
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037301067
• UDI-Public: 03701037301067
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Model Number: 311-0212
• Device Catalogue Number: 311-0212
• Device Lot Number: M2232
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization