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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FX SOLUTIONS HUMELOCK II; SHOULDER PROSTHESIS
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FX SOLUTIONS HUMELOCK II; SHOULDER PROSTHESIS Back to Search Results
Catalog Number 106-4600
Device Problem Microbial Contamination of Device (2303)
Patient Problem Unspecified Infection (1930)
Event Date 12/04/2019
Event Type  Injury  
Event Description
Revision surgery on (b)(6) 2019 due to infection approximately 3 months after patient's hemiarthroplasty surgery.During the revision, the surgeon explanted the 46x18 offset head to better assess the patient's infection, and then replaced it with a new offset head of the same size after debriding the infected tissue.
 
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Brand Name
HUMELOCK II
Type of Device
SHOULDER PROSTHESIS
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
samantha sterling
13465 midway rd
suite 101
dallas, TX 75244
2148904109
MDR Report Key9526362
MDR Text Key178018886
Report Number3014128390-2019-00077
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123814
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number106-4600
Device Lot NumberM1048
Was Device Available for Evaluation? No
Date Manufacturer Received12/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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;
Patient Age57 YR
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