BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM REVISION SHELL 62MM

    MDR report key: 10195741 · Received June 25, 2020

    Report

    Report Number
    0001822565-2020-02276
    Event Type
    Injury
    Date Received
    June 25, 2020
    Date of Event
    September 2, 2014
    Report Date
    June 25, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K001759
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (B)(4), PARSIPPANY TMT.

    Description of Event or Problem · 0

    VOID- INCORRECT MFG LOCATION.

    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. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ADDITIONAL ASSOCIATED PRODUCTS: 00712306254 2515216 TM SHT FLANGE CAGE RT 62/64 SHELL/54 LINER. 00711505228 62427735 TM REV SHELL CEMENTED CONST LINER 52X28. 00662406535 62615479 HGP II ACETABULAR CUP BONE SCREW SELF-TAP 6.5X35MM. 00662406535 62349491 HGP II ACETABULAR CUP BONE SCREW SELF-TAP 6.5X35MM. 00662406535 62490806 HGP II ACETABULAR CUP BONE SCREW SELF-TAP 6.5X35MM. 00662406540 62400517 HGP II ACETABULAR CUP BONE SCREW SELF-TAP 6.5X40MM. 00662406515 62529458 HGP II ACETABULAR CUP BONE SCREW SELF-TAP 6.5X15MM. 00662406525 62490787 HGP II ACETABULAR CUP BONE SCREW SELF-TAP 6.5X25MM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 6 MONTHS POST IMPLANTATION DUE TO FAILED ACETABULAR COMPONENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659382 TM REVISION SHELL 62MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 62434570

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEE H10 NARRATIVE.