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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 M; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 M; HIP COMPONENT Back to Search Results
Model Number PHA04410
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, a patient was revised for dislocation.Components not revised: product name: profemur® r prox body plasma spray x-small modular product id: ppw38354.Product name: profemur® roughened distal stem, tapered product id: ppw38022.Product name: profemur® modular femoral neck product id: pha01224.
 
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Brand Name
FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 M
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key12421621
Report Number3010536692-2021-00491
Device Sequence Number3332819
Product Code LZO
UDI-Device IdentifierM684PHA044101
UDI-PublicM684PHA044101
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K130376
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2010
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,study
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/28/2021
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 NumberPHA04410
Device Catalogue NumberPHA04410
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/12/2021
Initial Date Received by Manufacturer 08/12/2021
Supplement Date Received by Manufacturer08/12/2021
Initial Report FDA Received Date09/03/2021
Supplement Report FDA Received Date10/28/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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