BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 32/+3MM (T1)

    MDR report key: 2912654 · Received January 13, 2013

    Report

    Report Number
    3002806535-2013-00004
    Event Type
    Injury
    Date Received
    January 13, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PK051411
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. NO PRODUCT HAS BEEN RETURNED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THIS IS 2 OF 2 MDRS SUBMITTED FOR THE SAME EVENT. (SEE 3002806535-2013-00003/004).

    Additional Manufacturer Narrative · 1

    THE RETURNED COMPONENTS WERE EVALUATED AND APPEAR TO BE IN GOOD CONDITION, WITH THE EXCEPTION OF SOME SCRATCHING ON THE BEARING SURFACE OF THE LINER AND SOME METAL TRANSFER ON BOTH THE INSIDE TAPER AND THE EXTERNAL BEARING SURFACES OF THE CERAMIC HEAD. THERE IS QUITE A LOT OF BONE ATTACHMENT ON THE SHELL AND THE LATERAL ASPECT OF THE STEM CONSIDERING THE RELATIVELY SHORT IMPLANTATION TIME. THERE IS A SMALL AMOUNT OF HA THAT IS REMAINING ON THE STEM AND STABILITY WOULD SEEM TO HAVE BEEN GOOD DUE TO THE DEGREE OF BONE ATTACHMENT. THE SCRATCHING ON THE LINER IS PROBABLY DUE TO THIRD BODY DEBRIS, THE SOURCE OF WHICH IS UNCLEAR ALTHOUGH THERE WAS A LOT OF BONE DEBRIS IN AND AROUND THE RETRIEVED COMPONENTS. THE MARKING SEEN ON THE HEAD IS PROBABLY METAL TRANSFER FROM THE SHELL, WHICH WOULD HAVE BEEN LIKELY ONCE THE HEAD HAD DISLOCATED. THE COMPONENTS SELECTED COULD INDICATE THAT THERE WAS AN INITIAL CONCERN WITH DISLOCATION OR SOFT TISSUE LAXITY FOR THIS PATIENT. THIS IS IMPOSSIBLE TO ASSESS WITHOUT SURGICAL REPORTS AND RADIOGRAPHS. IT DOES NOT APPEAR THAT THE REVISION WAS DUE TO MECHANICAL FAILURE OF THE IMPLANTS. THE RECURRENT DISLOCATION COULD BE DUE TO MANY POSSIBLE REASONS BUT THESE CANNOT BE DETERMINED WITH THE EVIDENCE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT PRIMARY HIP PROCEDURE ON (B)(6) 2012. REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO DISLOCATION AND INSTABILITY. NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19456 DELTA CERAMIC FEM HD 32/+3MM (T1) BIOLOX CERAMIC HEAD LZO BIOMET UK LTD. N/A 2736316

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R