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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 Insufficient Information (4580)
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.
 
Additional Manufacturer Narrative
Additional information received on 02-sep-21.Part number for head component is pha04408 instead of ppt10240, which is not commercially available in the us.Please void this report.
 
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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 Key12388662
Report Number3010536692-2021-00464
Device Sequence Number20105677
Product Code LZO
UDI-Device IdentifierM684PHA044081
UDI-PublicM684PHA044081
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K130376
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2006
Device Explanted Year2006
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,study
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/01/2021
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
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 Date08/30/2021
Supplement Report FDA Received Date10/01/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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