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

Model Number Ø32/08 CEMENTLESS LOCKABLE

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

Patient Problems Failure of Implant (1924); Joint Laxity (4526)

Event Date 02/04/2021

Event Type  Injury  

Manufacturer Narrative

This mdr has already been submitted to fda by the us importer with report number (b)(4).

Event Description

Patient revised on (b)(6) 2021 due to a loose stem, approximately 1 year after primary surgery.Surgeon explanted the 32/08 humelock reverse stem, 36/+9 standard humeral cup, and +9mm humeral spacer, and replaced them with a new 32/08 humelock reverse stem secured with two cortical screws, a 36/+9 stability humeral cup, and a +9mm humeral spacer.

• 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: cedric joly ; 1663 rue des majornas; viriat, 01440 ; FR 01440
• MDR Report Key: 11528037
• MDR Text Key: 241058128
• Report Number: 3009532798-2021-00028
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037303696
• UDI-Public: 03701037303696
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/18/2021

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: 04/01/2024
• Device Model Number: Ø32/08 CEMENTLESS LOCKABLE
• Device Catalogue Number: 317-3208
• Device Lot Number: N0067
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2019
• 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