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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. LINEAGE(R) TRANSCEND(R) CERAMIC FEMORAL HEAD; HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. LINEAGE(R) TRANSCEND(R) CERAMIC FEMORAL HEAD; HIP COMPONENT Back to Search Results
Catalog Number 2600-0008
Device Problem Corroded (1131)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
This complaint will be updated once investigation is complete.Trends will be evaluated.
 
Event Description
Allegedly the patient alleged after six months of being implanted, she suffered many problems because of the corrosion of the protein materials.
 
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Brand Name
LINEAGE(R) TRANSCEND(R) CERAMIC FEMORAL HEAD
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 Key6974187
MDR Text Key90120906
Report Number3010536692-2017-01368
Device Sequence Number1
Product Code MRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/10/2017
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 Catalogue Number2600-0008
Device Lot Number019792884
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Distributor Facility Aware Date10/10/2017
Initial Date Manufacturer Received 10/10/2017
Initial Date FDA Received10/24/2017
Supplement Dates Manufacturer Received10/10/2017
Supplement Dates FDA Received12/22/2017
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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