BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HEAD

    MDR report key: 7278852 · Received February 16, 2018

    Report

    Report Number
    0001825034-2018-01101
    Event Type
    Injury
    Date Received
    February 16, 2018
    Date of Event
    May 18, 2012
    Report Date
    May 10, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN, UNKNOWN ACROS STEM, UNKNOWN.

    Additional Manufacturer Narrative · 1

    POSSIBLE PRODUCT: MODULAR HEAD COMPONENT. CATALOG#: 163638, LOT#: 914830, EXP DATE: MAR 31, 2021. APR 9, 2012, G5: K974558, H4: MAR 8, 2011. IT IS UNKNOWN IF THIS DEVICE WAS IMPLANTED IN THE LEFT OR RIGHT HIP AT THE TIME OF REVISION. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN ARCOS PROXIMAL CONE BODY, CATALOG#: NI, LOT#: NI UNKNOWN ARCOS DISTAL STEM, CATALOG#: NI, LOT#: NI UNKNOWN SCREW, CATALOG#: NI, LOT#: NI UNKNOWN STRYKER LINER, CATALOG#: NI, LOT#: NI UNKNOWN STRYKER CUP, CATALOG#: NI, LOT#: NI REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES AND X-RAY REVIEW. REVISION OP NOTES SHOW THE PATIENT WAS REVISED ON THE LEFT SIDE DUE TO INSTABILITY, DISLOCATION AND GREATER TROCHANTER NONUNION. HEAD AND LINER WERE REMOVED. MULTIPLE KINAMED ISO-ELASTIC CABLES WERE THEN USED TO FIX THE TROCHANTER ON PROXIMAL FEMORAL BODY. THE PREVIOUS FEMORAL ALLOGRAFT WAS REMOVED WITHOUT DIFFICULTY. REVIEW OF PRE-REVISION X-RAY SHOWS: RADIOLUCENCY IS PRESENT AT THE TIP OF THE FEMORAL STEM SUGGESTING LOOSENING. THERE IS A SLIGHT ORIENTATION CHANGE OF ONE OF THE SCREWS TRAVERSING THE FEMORAL STEM, SUGGESTING SCREW LOOSENING. GREATER TROCHANTERIC FRACTURE FRAGMENT HAS MOVED PROXIMALLY. AMORPHOUS BONE GRAFT MATERIAL APPEARS TO HAVE RESORBED LEAVING UNUNITED LATERAL BONE CORTICAL FRAGMENTS ALONG THE PROXIMAL FEMORAL SHAFT. UNUNITED PROXIMAL MEDIAL FEMORAL SHAFT CORTICAL FRAGMENT IS ALSO NOTED. HARDWARE APPEARS TO REMAIN INTACT. RADIOLUCENCIES ARE PRESENT AT THE SUPERIOR AND INFERIOR ACETABULAR CUP METAL BONE INTERFACE CONSISTENT WITH LOOSENING. THE FEMORAL HEAD COMPONENT IS CENTERED WITHIN THE ACETABULAR CUP COMPONENT. ACETABULAR CUP LATERAL ANGLE OF INCLINATION AND ANTEVERSION IS NOT REPORTED DUE TO EXCLUSION OF CONTRALATERAL BONY LANDMARKS AND LACK OF LATERAL VIEW. BONE QUALITY IS OSTEOPENIC. DHR WAS REVIEWED FOR POSSIBLE PRODUCT, AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF THE RIGHT HIP DUE TO DISLOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION AND INSTABILITY. THE PATIENT UNDERWENT OPEN TREATMENT AND REPAIR OF GREATER TROCHANTER FRACTURE NON-UNION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION, INSTABILITY, AND FRACTURE NON-UNION. ZIMMER BIOMET FEMORAL HEAD AND STRYKER LINER WERE REVISED. A STRYKER CONSTRAINED LINER AND NEW ZIMMER BIOMET HEAD WERE IMPLANTED, AND MULTIPLE KINAMED ISO-ELASTIC CABLES WERE USED TO FIX THE TROCHANTER ON THE PROXIMAL FEMORAL BODY. PREVIOUS FEMORAL ALLOGRAFT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120442 UNKNOWN HEAD PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R