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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIMED INC. FUSION CUP, 10 HOLE, 18MM
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TRIMED INC. FUSION CUP, 10 HOLE, 18MM Back to Search Results
Model Number FC10
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Arthritis (1723); Rheumatoid Arthritis (1724)
Event Date 12/08/2022
Event Type  malfunction  
Event Description
(b)(6) reported on (b)(6)2022 that he would like to return a fc10 marked with "do not implant" on it.It was reported that this item did not come in contact with a patient and did not cause additional harm.The item is available to be returned.Pictures are available.
 
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Brand Name
FUSION CUP, 10 HOLE, 18MM
Type of Device
FUSION CUP, 10 HOLE, 18MM
Manufacturer (Section D)
TRIMED INC.
27533 ave hopkins
santa clarita CA 91355
Manufacturer (Section G)
TRIMED, INC.
27533 ave hopkins
santa clarita CA 91355
Manufacturer Contact
megan rissler
27533 ave hopkins
santa clarita, CA 91355
6612557406
MDR Report Key15993139
MDR Text Key308273891
Report Number2031009-2022-00006
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00842188100734
UDI-Public00842188100734
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050681
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 12/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFC10
Device Catalogue NumberFC10
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/03/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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