BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER STANDARD OFFSET SIZE 1 130 MM STEM LENGTH

    MDR report key: 8018700 · Received October 30, 2018

    Report

    Report Number
    0002648920-2018-00762
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    December 12, 2014
    Report Date
    February 8, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    K960658
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THIS REPORT IS A DUPLICATE OF 0002648920-2017-00593. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. IF ADDITIONAL INFORMATION REGARDING THIS EVENT IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED UNDER 0002648920-2017-00593.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THIS REPORT IS A DUPLICATE OF 0002648920-2017-00593. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. IF ADDITIONAL INFORMATION REGARDING THIS EVENT IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED UNDER 0002648920-2017-00593.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 00801802802, ITEM NAME: FEMORAL HEAD +0X28MM DIA, LOT #: 62716383, ITEM NUMBER: 3003940002, ITEM NAME: REFOBACIN BONE CEMENT R 2X40G, LOT #: B416AF1631, ITEM NUMBER: 00-8011-020-20, ITEM NAME:ALLEN PLUG HDPE/BASO4 10C/20FL, LOT #: 62762801, ITEM NUMBER: RM 4901 000 5, ITEM NAME: ORTHODYNAMICS ACETABULAR CUP, LOT #: 1403121A ITEM NUMBER: RM 5110 003 5, ITEM NAME: ORTHODYNAMIC ACETABULAR LINER, LOT #: 1309190A. (B)(6). 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 PATIENT UNDERWENT HIP REVISION DUE TO PERIPROSTHETIC FRACTURE APPROXIMATELY TWO MONTHS POST-IMPLANTATION. THE STEM COMPONENT WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859577 FEMORAL STEM 12/14 NECK TAPER STANDARD OFFSET SIZE 1 130 MM STEM LENGTH PROSTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. N/A 62789528

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R