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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. UNKNOW ADVANCE MEDIAL PIVOT SYSTEM; KNEE COMPONENT
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MICROPORT ORTHOPEDICS INC. UNKNOW ADVANCE MEDIAL PIVOT SYSTEM; KNEE COMPONENT Back to Search Results
Model Number KIXXXXXX
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Event Description
Allegedly, a study was published in the belgian orthopedic act on medial pivot total knee arthroplasty, in which there were 304 cases of which 12 had complications and 5 ended in revision surgery.Four of these revisions occurred due to an infection, the first patient will be captured in this incident while the other 3 will be captured in groups 23120111, 23120112 and 23120113.
 
Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
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Brand Name
UNKNOW ADVANCE MEDIAL PIVOT SYSTEM
Type of Device
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer Contact
rachael wise
5677 airline road
arlington, TN 38002
9018674771
MDR Report Key18411191
MDR Text Key331526112
Report Number3010536692-2023-00241
Device Sequence Number1
Product Code JDI
Combination Product (y/n)N
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/28/2023
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 Model NumberKIXXXXXX
Device Catalogue NumberKIXXXXXX
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/11/2023
Initial Date FDA Received12/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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