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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY COCR LINER HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. DYNASTY COCR LINER HIP COMPONENT Back to Search Results
Model Number DLCOGC36
Device Problems Material Disintegration (1177); Device Dislodged or Dislocated (2923)
Patient Problems Metal Related Pathology (4530); Unequal Limb Length (4534)
Event Type  Injury  
Manufacturer Narrative
See investigation attached.
 
Event Description
Allegedly, the patient underwent a revision surgery due to dislocation, metal debris with pseudo - tumor formation and leg length discrepancy. Component not revised: dspcgc50 dynasty® pc shell 50mm group c lot: 129999843.
 
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Brand NameDYNASTY COCR LINER
Type of DeviceHIP 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 Key11230243
MDR Text Key228675027
Report Number3010536692-2021-00041
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDLCOGC36
Device Catalogue NumberDLCOGC36
Device Lot Number0301068674
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/05/2021
Event Location No Information
Date Manufacturer Received01/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/26/2021 Patient Sequence Number: 1
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