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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 - 32 S; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 S; HIP COMPONENT Back to Search Results
Model Number PHA04408
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
Event or Problem Description
Allegedly, patient was revised due to dislocation/subluxation.Revision njr number: (b)(4).Side:l.Primary asa: p2 - mild disease not incapacitating.Component not revised: profemur xm stem size 0 / product id: pha06000 / lot no.: 1659776.Profemur® neck neutral short / product id: pha01202 / lot no.: 1666220.Profemur® xm distal centralizer / product id: prxmdc01 / lot no.: 15571341622616.Mhra reference no: (b)(4).
 
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Brand Name
FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 S
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key11659546
Report Number3010536692-2021-00207
Device Sequence Number14227498
Product Code LZO
UDI-Device IdentifierM684PHA044081
UDI-PublicM684PHA044081
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K130376
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/10/2021
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 Other
Device Model NumberPHA04408
Device Catalogue NumberPHA04408
Device Lot Number15530321625889
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/22/2021
Initial Date Received by Manufacturer 03/22/2021
Supplement Date Received by Manufacturer03/22/2021
Initial Report FDA Received Date04/13/2021
Supplement Report FDA Received Date06/10/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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