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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
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 NameFEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M
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 Key9769801
Report Number3010536692-2020-00163
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial
Report Date 02/28/2020
1 Device Was Involved in the Event
0 PatientS WERE 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
Event Location No Information
Date Manufacturer Received10/24/2019
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

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