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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 DLCOGG44
Device Problems Corroded (1131); Material Disintegration (1177)
Patient Problem Reaction (2414)
Event Type  Injury  
Event Description
Allegedly, patient revised due to metal debris, corrosion, pseudotumors and resultant metal ions.Additional information: right hip.Components were removed , including the metal liner and metal femoral head, the shell and stem were retained.Additional information received on 07/20/2020 : adding product numbers and lot id's.
 
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Brand Name
DYNASTY COCR LINER
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 Key10401850
MDR Text Key202732752
Report Number3010536692-2020-00570
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 other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberDLCOGG44
Device Catalogue NumberDLCOGG44
Device Lot Number077447460
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/20/2020
Date Manufacturer Received07/20/2020
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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