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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GUARDIAN(R) TIBIAL SLEEVE SPACER; HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. GUARDIAN(R) TIBIAL SLEEVE SPACER; HIP COMPONENT Back to Search Results
Model Number 2500-1208
Device Problem Insufficient Information (3190)
Patient Problem Osteolysis (2377)
Event Type  Injury  
Manufacturer Narrative
This complaint will be updated once investigation is complete.Trends will be evaluated.
 
Event Description
Allegedly, patient was revised due to aseptic loosening femur; aseptic loosening tibia, lysis femur; lysis tibia (right).
 
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Brand Name
GUARDIAN(R) TIBIAL SLEEVE SPACER
Type of Device
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer (Section G)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer Contact
5677 airline road
arlington, TN 38002
9018674771
MDR Report Key7809519
MDR Text Key118010249
Report Number3010536692-2018-01089
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K013035
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 08/23/2018
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 Other
Device Model Number2500-1208
Device Catalogue Number2500-1208
Device Lot Number1529177
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/13/2018
Initial Date Manufacturer Received 08/13/2018
Initial Date FDA Received08/23/2018
Supplement Dates Manufacturer Received08/13/2018
Supplement Dates FDA Received12/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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