BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINA V40-FEMORAL HEAD 28MM, +0MM NK

    MDR report key: 4632679 · Received March 25, 2015

    Report

    Report Number
    0002249697-2015-00899
    Event Type
    Injury
    Date Received
    March 25, 2015
    Date of Event
    January 1, 2013
    Report Date
    March 2, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K023901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING MALPOSITION INVOLVING BOTH AN UNKNOWN OMNIFIT STEM AND UNKNOWN TRIDENT SHELL WAS REPORTED. THE MATERIAL ANALYSIS CONCLUDED: "BOTH THE CERAMIC HEAD AND INSERT/SLEEVE INDICATED EVIDENCE OF WEAR SCARRING AND EXPLANTATION DAMAGE. MATERIAL DAMAGE LIKELY DUE TO IMPINGEMENT WAS OBSERVED ON THE DISTAL SLEEVE RIM. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON ANY OF THE COMPONENTS EXAMINED." A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSION: BASED ON THE PROVIDED INFORMATION AND THE MEDICAL PERFORMED THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT. ROOT CAUSE OF FAILURE IN THIS CASE IS RELATED TO COMPONENT MALPOSITION OF BOTH THE STEM AND THE SHELL. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT THA DUE TO OA WITH CERAMIC ON CERAMIC FOR RIGHT HIP ON (B)(6) 2008. OSTEOLYSIS WAS NOTICED ON 2013 AT FEMORAL SIDE AND ACETABULAR SIDE. (B)(6) 2015, ALUMINA CERAMIC CUP AND ALUMINA CERAMIC LINER WERE REPLACED TO X3 POLY LINER AND DELTA CERAMIC.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT THA DUE TO OA WITH CERAMIC ON CERAMIC FOR RIGHT HIP ON (B)(6) 2008. OSTEOLYSIS WAS NOTICED ON 2013 AT FEMORAL SIDE AND ACETABULAR SIDE. (B)(6) 2015, ALUMINA CERAMIC CUP AND ALUMINA CERAMIC LINER WERE REPLACED TO X3 POLY LINER AND DELTA CERAMIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200042 ALUMINA V40-FEMORAL HEAD 28MM, +0MM NK IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 24163401

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R