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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
Model Number GLJG-2644
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
This complaint will be updated once the investigation is complete.Trends will be evaluated.
 
Event Description
Allegedly, primary surgery was performed at (b)(6) 2019.The surgeon found a dissociation after surgery.The surgeon performed revision surgery on (b)(6) 2019.The cup, head and neck will be returned.
 
Event Description
Allegedly, primary surgery was performed at (b)(6) 2019.The surgeon found a dissociation after surgery.The surgeon performed revision surgery on january 11, 2019.The cup, head and neck will be returned.
 
Manufacturer Narrative
The products were returned for evaluation.This complaint is confirmed.There were no trends identified.This issue will continue to be monitored through complaint tracking.
 
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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
MDR Report Key8333335
MDR Text Key135953653
Report Number3010536692-2019-00376
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 02/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberGLJG-2644
Device Catalogue NumberGLJG-2644
Device Lot Number1765992
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/29/2019
Date Manufacturer Received01/29/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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