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

Model Number DIAMETER 36 mm CENTERED

Device Problems Device Dislodged or Dislocated (2923); Inadequate User Interface (2958)

Patient Problem Failure of Implant (1924)

Event Date 03/09/2021

Event Type  Injury  

Manufacturer Narrative

This mdr has already been submitted to fda by the us importer with report number 3014128390-2021-00012.

Event Description

Patient revised for the second time on (b)(6) 2021 due to dislocation from non-compliance with post-operative instructions, approximately 5 days after first revision (poly swap due to non-compliance ; exchanged 36/+3 standard cup for 36/+6 stability cup) and 3 weeks after primary surgery.Surgeon explanted the 36/+6 stability humeral cup and 36mm centered glenosphere with screw, and replaced them with a 36/+9 stability humeral cup and 36mm eccentric glenosphere with screw.

• Brand Name: HUMELOCK REVERSED
• Type of Device: REVERSED 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: 11670230
• MDR Text Key: 245558355
• Report Number: 3009532798-2021-00044
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 03701037300268
• UDI-Public: 03701037300268
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150488
• 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: 04/15/2021

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: No Information
• Device Model Number: DIAMETER 36 mm CENTERED
• Device Catalogue Number: 105-3610
• Device Lot Number: N3427
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2020
• 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
• Patient Age: 68 YR