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

Model Number UNIQUE SIZE

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 02/17/2021

Event Type  Injury  

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 Description

The event was a revision surgery due to baseplate loosening that occured approximately 20 months after the primary surgery.The primary surgery used the humelock reversed system.The patient was an old woman.The surgeon explanted the ø24 baseplate and the ø36/+6 humeral cup and implanted a ø24/ø10 eccentric taper adapter and a ø48 helmet head.

• Brand Name: HUMELOCK REVERSED
• Type of Device: REVERSE SHOULDER PROSTHESIS
• 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: 11641744
• MDR Text Key: 244661861
• Report Number: 3009532798-2021-00041
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037300237
• UDI-Public: 03701037300237
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/07/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2024
• Device Model Number: UNIQUE SIZE
• Device Catalogue Number: 105-0024
• Device Lot Number: N0032
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 04/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2019
• 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; Required Intervention