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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GLADIATOR(R) BIPOLAR; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. GLADIATOR(R) BIPOLAR; HIP COMPONENT Back to Search Results
Catalog Number GLBP-3650
Device Problem Disassembly (1168)
Patient Problem No Information (3190)
Event Date 06/16/2017
Event Type  Injury  
Manufacturer Narrative
This complaint will be updated once investigation is complete.Trends will be evaluated.
 
Event Description
Allegedly the patient presented to the emergency room with a dislocated bi-polar hip.The gladiator bi-polar shell had become disassociated from the femoral head.The surgeon removed the bi-polar shell without difficulty or use of femoral tool.He then implanted a new bi-polar shell on the femoral head.
 
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Brand Name
GLADIATOR(R) BIPOLAR
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 Key6671695
MDR Text Key78541359
Report Number3010536692-2017-00886
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue NumberGLBP-3650
Device Lot Number1409743
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date06/23/2017
Date Manufacturer Received06/23/2017
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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