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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 DLCOGE40
Device Problem Material Disintegration (1177)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)
Event Type  Injury  
Event Description
Allegedly, patient underwent a right total hip replacement and received a metal on metal wright hip system implants.Patient suffered pain, debilitating lack of mobility, and high levels of toxic metal levels.
 
Manufacturer Narrative
Section b5: additional information in description / section b5: explant date added / section h6 health code 4530 added.
 
Event Description
Allegedly, patient underwent a right total hip replacement and received a metal on metal wright hip system implants.Patient suffered pain, debilitating lack of mobility, and high levels of toxic metal levels.Additional information received on 08/11/2021 from legal department: adding revision surgery date for right hip on (b)(6) 2020).
 
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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
MDR Report Key10474388
MDR Text Key205302921
Report Number3010536692-2020-00593
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 11/04/2021
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
Device Operator Other
Device Model NumberDLCOGE40
Device Catalogue NumberDLCOGE40
Device Lot Number07635778210
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/17/2020
Initial Date Manufacturer Received 08/17/2020
Initial Date FDA Received08/31/2020
Supplement Dates Manufacturer Received08/17/2020
Supplement Dates FDA Received11/04/2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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