BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI-METRIC HIP LATERALISED FEMORAL STEM

    MDR report key: 6374660 · Received March 2, 2017

    Report

    Report Number
    3002806535-2017-00104
    Event Type
    Injury
    Date Received
    March 2, 2017
    Date of Event
    January 26, 2017
    Report Date
    April 6, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. (B)(4). CONCOMITANT PRODUCTS: PN 163669, LN 00J3637187, 32MM MOD HD COCR STD. UNKNOWN ACETABULAR SHELL. UNKNOWN ACETABULAR LINER. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THE REPORTED DEVICE IS SIMILAR TO A DEVICE MANUFACTURED AT ZIMMER BIOMET (B)(4) UNDER 510K NUMBER K921224.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ONSET OF PAIN OCCURRED (B)(6) OF AN UNKNOWN YEAR. THERAPY DATE - ONSET OF PAIN OCCURRED (B)(6) OF AN UNKNOWN YEAR. MEDICAL PRODUCT - EXCEED ACETABULAR CUP CATALOG#: 131358 LOT#: 3515668, RINGLOC X ACETABULAR LINER CATALOG#: XL-053258 LOT#: 3332949.

    Description of Event or Problem · 1

    PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY FIVE MONTHS POST-IMPLANTATION DUE TO FEMORAL STEM LOOSENING. THE FEMORAL STEM AND HEAD WERE REVISED.

    Description of Event or Problem · 1

    PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY FIVE MONTHS POST-IMPLANTATION DUE TO PAIN AND FEMORAL STEM LOOSENING. THE FEMORAL STEM AND HEAD WERE REVISED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154986 BI-METRIC HIP LATERALISED FEMORAL STEM PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 3612895

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R