BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 40MM

    MDR report key: 7785658 · Received August 15, 2018

    Report

    Report Number
    0001825034-2018-04292
    Event Type
    Injury
    Date Received
    August 15, 2018
    Date of Event
    May 2, 2018
    Report Date
    November 1, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. THE COMPONENTS WERE REVIEWED FOR COMPATIBILITY AND IT WAS DETERMINED THAT G7 LINER 4 WAS NOT COMPATIBLE WITH TRABECULAR METAL ACETABULAR REVISION SHELL. ZIMMER-BIOMET HAS NOT CONFIRMED THE COMPATIBILITY OF THIS COMBINATION OF DEVICES, AND THIS WOULD BE CONSIDERED AN OFF-LABEL USE OF THIS PRODUCT AS INDICATED ON THE PACKAGING INSERT. HOWEVER, IT IS UNKNOWN WHETHER THIS CAUSED OR CONTRIBUTED TO THE DISLOCATION. IN ADDITION, A FALL WAS NOTED, HOWEVER, IT IS UNKNOWN THE CAUSE OF THE FALL, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 · 0

    IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION AFTER A FALL 7 MONTHS POST IMPLANTATION. THE PATIENT FELL AND HAD A SUBLUXATION/DISLOCATION OF THE HIP. OPEN REDUCTION WAS PERFORMED AND IT WAS NOTED THE HIP WAS SUBLUXED POSTERIORLY DUE TO FRACTURE OF THE CEMENT AND WAS NOT REDUCIBLE BY CLOSED REDUCTION. THE REVISION SURGERY WAS PERFORMED TO REPLACE THE HEAD AND LINER, LEAVING ONLY THE TRABECULAR METAL CUP THAT WAS SOLIDLY FIXED. NOTED HIP ABDUCTION AND INTERNAL ROTATION HAD TIGHTNESS WAS DUE SOFT TISSUE SCARRING WHICH COULD NOT BE RELEASED W/OUT IMPAIRING FUNCTION.

    Additional Manufacturer Narrative · 1

    (B)(4). UNIQUE IDENTIFIER (UDI) #: N/A. CONCOMITANT MEDICAL PRODUCTS: 00700006220, TRABECULAR METAL ACETABULAR REVISION SHELL, 63641611. 010000942, G7 HI-WALL E1 LINER 40MM F, 3873829. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-04293. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION AFTER A FALL 7 MONTHS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628131 CER BIOLOXD OPTION HD 40MM PROSTHESIS. HIP LZO ZIMMER BIOMET, INC. N/A 2907293

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R