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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GLADIATOR® BIPOLAR 51MM OD X 36MM ID; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. GLADIATOR® BIPOLAR 51MM OD X 36MM ID; HIP COMPONENT Back to Search Results
Model Number GLBP3651
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Information (3190)
Date of Event 05/08/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event or Problem Description
Allegedly, primary surgery was preformed on (b)(6) 2016.The surgeon found a dissociation after surgery and mentioned excessive stress , may have occurred during agricultural work.The surgeon performed revision surgery on (b)(6) 2019.We will not return at this time.
 
Event or Problem Description
Allegedly, primary surgery was preformed on (b)(6) 2016.The surgeon found a dissociation after surgery and mentioned excessive stress, may have occurred during agricultural work.
 
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Brand Name
GLADIATOR® BIPOLAR 51MM OD X 36MM ID
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key8758299
Report Number3010536692-2019-00892
Device Sequence Number13850834
Product Code KWY
UDI-Device IdentifierM684GLBP36511
UDI-PublicM684GLBP36511
Combination Product (Y/N)N
PMA/510(K) Number
K062693
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 02/07/2020
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
Operator of Device Other
Device Model NumberGLBP3651
Device Catalogue NumberGLBP3651
Device Lot Number14697101591839
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/06/2019
Initial Date Received by Manufacturer 06/06/2019
Supplement Date Received by Manufacturer06/06/2019
Initial Report FDA Received Date07/03/2019
Supplement Report FDA Received Date02/07/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age77 YR
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