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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  
Manufacturer Narrative
See investigation attached. (b)(4).
 
Event Description
Allegedly, patient revised due to metal debris, corrosion, pseudotumors and resultant metal ions. Additional information: left 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?.
 
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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 Key10396783
MDR Text Key202566654
Report Number3010536692-2020-00565
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 company representative
Reporter Occupation
Type of Report Initial
Report Date 08/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDLCOGG44
Device Catalogue NumberDLCOGG44
Device Lot Number117495712
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
Event Location No Information
Date Manufacturer Received07/20/2020
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 Initial

Patient Treatment Data
Date Received: 08/12/2020 Patient Sequence Number: 1
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