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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FX SOLUTIONS HUMERIS; SHOULDER PROTHESIS

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FX SOLUTIONS HUMERIS; SHOULDER PROTHESIS Back to Search Results
Model Number 106-4300
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 07/08/2020
Event Type  Injury  
Event Description
Patient revised on (b)(6) 2020, approximately 15 months after the primary surgery on (b)(6) 2019.According to the field representative, the patient needed to have a muscle transfer done due to a brachial plexus injury and was not a candidate for a reverse prosthesis.In order to make room in the joint for the transfer, the surgeon explanted the 43x17 offset cocr head and +0mm double taper, and replaced them with a 41x16 offset cocr head and a new +0mm double taper.
 
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Brand Name
HUMERIS
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
cédric joly
1663 rue de majornas
viriat, 01440
FR   01440
MDR Report Key10338241
MDR Text Key200799060
Report Number3009532798-2020-00300
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111097
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 07/29/2020
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 Expiration Date05/01/2023
Device Model Number106-4300
Device Lot NumberM1046
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/10/2020
Initial Date FDA Received07/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/05/2018
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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