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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 -40 M; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 -40 M; HIP COMPONENT Back to Search Results
Model Number PHA04422
Health Effect - Clinical Code Unspecified Infection (1930)
Type of Reportable Event Serious Injury
Event or Problem Description
Allegedly, patient was revised due to infection revision njr number: (b)(4).Side:r.Primary asa: p2 - mild disease not incapacitating.Components not revised : procotyl l beaded and ha coated cup size 56mm, product number: pha06266, lot number: 1816180.Profemur tl classic fixed neck size 7 product number: prtls027, lot number: 1832175, mhra reference no: (b)(4).
 
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Brand Name
FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 -40 M
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key11301192
Report Number3010536692-2021-00064
Device Sequence Number3368790
Product Code MRA
UDI-Device IdentifierM684PHA044221
UDI-PublicM684PHA044221
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K130376
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source foreign,other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 02/09/2021
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
Operator of Device Health Professional
Device Model NumberPHA04422
Device Catalogue NumberPHA04422
Device Lot Number1811985
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/21/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/21/2021
Initial Report FDA Received Date02/09/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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