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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 Codes Use of Device Problem (1670); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code No Information (3190)
Date of Event 04/07/2011
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluate.
 
Event or Problem Description
Allegedly, left hip endoprosthesis dislocation due to extensive internal rotation of the hip joint, closed reduction and immobilisation resolved the problem, no further instability of the enrolled hip.
 
Additional Manufacturer Narrative
Update initial reporter information.
 
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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 Key9954046
Report Number3010536692-2020-00338
Device Sequence Number2789154
Product Code LZO
UDI-Device IdentifierM684PHA044101
UDI-PublicM684PHA044101
Combination Product (Y/N)N
Initial Reporter CountryPL
PMA/510(K) Number
K130376
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 07/02/2020
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
Device Lot Number0701185761
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/25/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/25/2020
Supplement Date Received by Manufacturer03/25/2020
Initial Report FDA Received Date04/13/2020
Supplement Report FDA Received Date07/02/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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