BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTRAINED LINER

    MDR report key: 8192806 · Received December 21, 2018

    Report

    Report Number
    0001822565-2018-07077
    Event Type
    Injury
    Date Received
    December 21, 2018
    Date of Event
    May 8, 2017
    Report Date
    March 14, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    K071718
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

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

    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; 00-7125-056-48 LOT 2681547 TM LNG FLANGE CAGE; 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. MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0001822565 - 2018 - 06997.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUFFERED BLOOD LOSS OF 1200 CC REQUIRING MEDICAL INTERVENTION. THE PATIENT RECEIVED 2 UNITS OF BLOOD THROUGH TRANSFUSION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031843 CONSTRAINED LINER HIP PROSTHESIS KWZ ZIMMER BIOMET, INC. N/A 62516425

    Patients

    Seq Age Sex Outcome Treatment
    1 Other