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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M; HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M; HIP COMPONENT Back to Search Results
Model Number PHA04416
Device Problem Noise, Audible (3273)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
Allegedly patient presented with pain and squeaking sounds, upon x-ray the liner showed disassociation.All mpo implants were explanted and replaced with another manufacturers system, apart from the femoral stem.(b)(6).
 
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Brand Name
FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M
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 Key9769801
MDR Text Key181377872
Report Number3010536692-2020-00163
Device Sequence Number1
Product Code LZO
UDI-Device IdentifierM684PHA044161
UDI-PublicM684PHA044161
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K130376
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 02/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberPHA04416
Device Catalogue NumberPHA04416
Device Lot Number1741752
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/24/2019
Date Manufacturer Received10/24/2019
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 Age40 YR
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