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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE A-CLASS BFH HEAD; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. CONSERVE A-CLASS BFH HEAD; HIP COMPONENT Back to Search Results
Model Number 38AM5200
Device Problem Fracture (1260)
Patient Problem Metal Related Pathology (4530)
Event Date 05/06/2020
Event Type  Injury  
Event Description
Allegedly, on (b)(6) 2020 the femoral neck of the device failed fracturing into two pieces, on that same date the device was surgically removed.During the revision procedure the doctor observed metallosis deep in the hip.(right hip).
 
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Brand Name
CONSERVE A-CLASS BFH 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 Key10800693
MDR Text Key215044816
Report Number3010536692-2020-00688
Device Sequence Number1
Product Code JDL
UDI-Device Identifier00192629060821
UDI-Public192629060821
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051348
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Physician
Type of Report Initial
Report Date 11/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number38AM5200
Device Catalogue Number38AM5200
Device Lot Number107482918
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/16/2020
Date Manufacturer Received10/16/2020
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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