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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 L; HIP COMPONENT
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MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 L; HIP COMPONENT Back to Search Results
Model Number PHA04412
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:r, primary asa: p2 - mild disease not incapacitating.
 
Additional Manufacturer Narrative
This incident is a duplicate event of the manufacturer report number: (b)(4).Please void the report.
 
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Brand Name
FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 L
Common Device Name
HIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key12451123
Report Number3010536692-2021-00517
Device Sequence Number3964822
Product Code LZO
UDI-Device IdentifierM684PHA044121
UDI-PublicM684PHA044121
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K130376
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
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 NumberPHA04412
Device Catalogue NumberPHA04412
Device Lot Number1884326
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/24/2021
Initial Date Received by Manufacturer 08/24/2021
Supplement Date Received by Manufacturer08/24/2021
Initial Report FDA Received Date09/09/2021
Supplement Report FDA Received Date10/01/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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