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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK II; SHOULDER PROTHESIS
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FX SOLUTIONS HUMELOCK II; SHOULDER PROTHESIS Back to Search Results
Catalog Number 311-0212
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Calcium Deposits/Calcification (1758)
Event Date 01/29/2019
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
Revision surgery occurred due to important calcifications (b)(6) 2019.All the component parts of the anatomical shoulder prothesis were removed and replaced by a reversed shoulder prothesis.Primary surgery occurred (b)(6) 2019.
 
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Brand Name
HUMELOCK II
Type of Device
SHOULDER PROTHESIS
Manufacturer (Section D)
FX SOLUTIONS
1663 rue de majornas
viriat, 01440
FR  01440
Manufacturer (Section G)
FX SOLUTIONS
1663 rue de majornas
viriat, 01440
FR   01440
Manufacturer Contact
cedric joly
1663 rue de majornas
viriat, 01440
FR   01440
MDR Report Key9835532
MDR Text Key189025497
Report Number3009532798-2020-19043
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K130759
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/01/2022
Device Catalogue Number311-0212
Device Lot NumberL1898
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2017
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;
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