BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETABULAR REVISION SYSTEM - CAGE, RIGHT LONG FLANGE

    MDR report key: 8196978 · Received December 26, 2018

    Report

    Report Number
    0001822565-2018-06996
    Event Type
    Injury
    Date Received
    December 26, 2018
    Date of Event
    May 8, 2017
    Report Date
    August 27, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K061226
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE SECOND REVISION OP NOTES SHOWS THE PATIENT WAS REVISED DUE TO PELVIC DISCONTINUITY. BONE GRAFT AND TRABECULAR CUP WERE USED AND THE PELVIS WAS RECONSTRUCTED BY THE SURGEON. THREE SCREWS WERE PUT, LINER WAS CEMENTED, AND THE SPACE BETWEEN TANTALUM AND THE CUP WAS FILLED WITH CEMENT. ESTIMATED BLOOD LOSS 700CC REQUIRING TWO UNITS OF BLOOD TO BE TRANSFUSED. 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.

    Additional Manufacturer Narrative · 0

    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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE REVISION, THE PATIENT SUFFERED 1200 CC BLOOD LOSS, REQUIRING 2 UNITS OF RBCS TO BE TRANSFUSED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 00-6250-065-25, LOT 63321767, BONE SCREW, 6.5X25 SELF-TAP. 00-6250-065-25, LOT 63131581, BONE SCREW, 6.5X25 SELF-TAP. 00-6250-065-25, LOT 63187329, BONE SCREW, 6.5X25 SELF-TAP. 00-6250-065-35, LOT 63165870, BONE SCREW, 6.5X35 SELF-TAP. 00-8018-028-01, LOT 63043511, 12/14 COCR FEMORAL HEAD, 28MM, -3.5. 00-9981-135-32, LOT 61943614, ZMR POROUS STEM, 13.5X170MM, BOWED. 00-7110-048-28, LOT 62725093, TM REV 10 DEG OBLIQUE LINER LONGEVITY, 48X28. 00-6334-050-28, LOT 62516425, TRILOGY LONGEVITY CONSTRAINED LINER, 50/52/54X28. 00-9993-018-45, LOT 62989652, ZMR CONE B BODY, 46X45MM, EXTENDED OFFSET. 00-7000-056-20, LOT 62620109, TRABECULAR METAL REVISION SHELL, 56MM. 00-6250-065-20, LOT 62793471, BONE SCREW, 6.5X20 SELF-TAP. 00-6250-065-20, LOT 63365454, BONE SCREW, 6.5X20 SELF-TAP. 00-6250-065-20, LOT 63272711, BONE SCREW, 6.5X20 SELF-TAP. 00-6250-065-40, LOT 62622414, BONE SCREW, 6.5X40 SELF-TAP. 00-6250-065-30, LOT 63380652, BONE SCREW, 6.5X30 SELF-TAP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY ONE YEAR POST IMPLANTATION DUE TO PELVIC DISCONTINUITY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037302 ACETABULAR REVISION SYSTEM - CAGE, RIGHT LONG FLANGE PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 2681547

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R