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U.S. Department of Health and Human Services

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

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MICROPORT ORTHOPEDICS INC. DYNASTY(R) COCR LINER HIP COMPONENT Back to Search Results
Model Number DLCO-GE40
Device Problems Corroded (1131); Material Disintegration (1177)
Patient Problem Reaction (2414)
Event Type  Injury  
Event Description
Allegedly the patient underwent a left total hip replacement performed by dr. (b)(6) on (b)(6) 2008; on the left side. Plaintiff also allegedly received an a-class head paired with a dnasty® shell and a cocr liner and a stelkast femoral stem. Plaintiff alleged he underwent a left hip revision surgery (b)(6) 2017, performed by dr. (b)(6), due to an adverse tissue reaction to metal debris, corrosion and resultant metal ions (left).
 
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Brand NameDYNASTY(R) 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 Key8425957
MDR Text Key138969867
Report Number3010536692-2019-00549
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 03/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberDLCO-GE40
Device Catalogue NumberDLCO-GE40
Device Lot Number078595479
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/05/2019
Event Location No Information
Date Manufacturer Received03/05/2019
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: 03/15/2019 Patient Sequence Number: 1
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