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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FX SOLUTIONS EASYTECH REVERSED; TOTAL ANATOMIC SHOULDER PROSTHESIS

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FX SOLUTIONS EASYTECH REVERSED; TOTAL ANATOMIC SHOULDER PROSTHESIS Back to Search Results
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/08/2021
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
Patient was revised on (b)(6) 2021 due to a dislocation, approximately 3 months after the first surgery.The surgeon explanted ø40+3 cup and implanted ø40+9 135/145° cup.
 
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Brand Name
EASYTECH REVERSED
Type of Device
TOTAL ANATOMIC 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 Key13077256
MDR Text Key283751603
Report Number3009532798-2021-00248
Device Sequence Number1
Product Code PKC
Combination Product (y/n)N
Reporter Country CodeFR
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 12/17/2021
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/09/2021
Initial Date FDA Received12/23/2021
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;
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