BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA OPTION CERAMIC HEAD

    MDR report key: 6231115 · Received January 6, 2017

    Report

    Report Number
    0001825034-2017-00076
    Event Type
    Injury
    Date Received
    January 6, 2017
    Date of Event
    May 18, 2016
    Report Date
    April 24, 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 · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL SUBMISSION WAS VOIDED. UPON REASSESSMENT, IT WAS DEEMED NECESSARY TO REPORT THE EVENT. CONCOMITANT MEDICAL PRODUCTS: 11-300920 ARCOS 20X190MM SPL TPR DIST M 051500, 650-1066 OPTION TAPER SLEEVE TI 0MM TYP E 1 561480, 11-301310 ARCOS CON SZ A HI 50MM M SZ A 293120, 00875705602 BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH 63213996, 00625006525 BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH 63124645, 00875501236 OBLIQUE LINER 36 MM I.D. SIZE KK FOR USE WITH 56 MM O.D. SIZE KK SHELL 63245567, 00223200205 INTEGRAL LONG GTR W/ 4 CABLES 56594802, 00875705602 SHELL WITH MULTI HOLES POROUS 56 MM O.D. SIZE KK FOR USE WITH KK LINERS 63236736. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES 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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION, THIS EVENT WAS DETERMINED TO BE NOT REPORTABLE. THE PATIENT HAS ONLY UNDERGONE ONE REVISION PROCEDURE AND IT IS REPORTED ON 1822565-2017-00067.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED APPROXIMATELY THREE (3) WEEKS POST-OPERATIVELY DUE TO DISLOCATION. A NEW FEMORAL HEAD WAS IMPLANTED AND A CONSTRAINED LINER WAS ALSO IMPLANTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11958 BIOLOX DELTA OPTION CERAMIC HEAD PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 667690

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R