Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FX SHOULDER SOLUTIONS HUMELOCK REVERSED; REVERSED SHOULDER PROTHESIS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FX SHOULDER SOLUTIONS HUMELOCK REVERSED; REVERSED SHOULDER PROTHESIS Back to Search Results
Catalog Number 312-3208
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Joint Laxity (4526)
Event Date 02/14/2024
Event Type  Injury  
Event Description
The patient was revised due to loosening on (b)(6) 2024.The implantation date was on (b)(6) 2020.A cup, a glenosphere and a stem were explanted.A cup, a glenosphere and a stem were implanted.
 
Manufacturer Narrative
The event took place outside the united states (in france) and was associated with a product that is also cleared for the market in the united states.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HUMELOCK REVERSED
Type of Device
REVERSED SHOULDER PROTHESIS
Manufacturer (Section D)
FX SHOULDER SOLUTIONS
1663 rue de majornas
viriat, 01440
FR  01440
Manufacturer (Section G)
FX SHOULDER SOLUTIONS
1663 rue de majornas
viriat, 01440
FR   01440
Manufacturer Contact
emeric obin
1663 rue de majornas
viriat, 01440
FR   01440
MDR Report Key18834858
MDR Text Key336852823
Report Number3009532798-2024-00017
Device Sequence Number1
Product Code PHX
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/04/2024
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 Catalogue Number312-3208
Device Lot NumberP0342
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/12/2024
Initial Date FDA Received03/05/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
-
-