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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. LINEAGE(R) TRANSCEND(R) METAL ACETABULAR LINER HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. LINEAGE(R) TRANSCEND(R) METAL ACETABULAR LINER HIP COMPONENT Back to Search Results
Model Number 7020-3252
Device Problem Insufficient Information (3190)
Patient Problems Osteolysis (2377); Reaction (2414)
Event Type  Injury  
Manufacturer Narrative
[(b)(4)].
 
Event Description
Allegedly, the patient was revised due to osteolysis (right hip) metal on metal construct (revision) modular neck and head were exchanged for new product. Dr. Would like neck tested for wear and corrosion due to osteolysis in the femur surrounding the implant. The following components have no alleged deficiency and were not revised during this surgery: lineage® acetabular shell 36430054 03470776; profemur® plasma z stem pha00262 u0163456.
 
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Brand NameLINEAGE(R) TRANSCEND(R) METAL ACETABULAR 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 Key7971376
MDR Text Key123934359
Report Number3010536692-2018-01315
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
Reporter Occupation
Type of Report Initial
Report Date 10/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number7020-3252
Device Catalogue Number7020-3252
Device Lot Number03457114
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/10/2018
Event Location No Information
Date Manufacturer Received10/10/2018
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: 10/16/2018 Patient Sequence Number: 1
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