BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HXPE LINER NEUT 58 LL X 36

    MDR report key: 8721844 · Received June 21, 2019

    Report

    Report Number
    0001822565-2019-02623
    Event Type
    Injury
    Date Received
    June 21, 2019
    Date of Event
    February 20, 2018
    Report Date
    October 9, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K151448
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # 00771102020, M/L TAPER FEMORAL STEM, LOT # 62540704. ITEM # 00801803603, VERSYS FEMORAL HEAD +3.5, LOT # 62618324. ITEM # 00875705801, CONTINUUM TM SHELL, LOT # 62601645. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2019-02621, STEM. 0002648920-2019-00339, HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN IN LEFT HIP ALONG WITH PSOAS TENDINITIS WITH FAILED CONSERVATIVE THERAPY. PRE-REVISION WORKUP REVEALED ELEVATED METAL IONS. LEFT THA REVISION WAS PERFORMED APPROXIMATELY 4 YEARS AFTER THE INITIAL SURGERY. SURGEON NOTED CORROSION ON NECK/HEAD JUNCTION, ALONG WITH PSEUDOTUMOR. AS THERE WAS LEG LENGTH DISCREPANCY PRIOR TO REVISION, SURGEON PERFORMED PSOAS LENGTHENING VERSES PERFORMING REVISION OF STEM TO CORRECT THE LENGTH. HEAD AND LINER WERE EXCHANGED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514694 HXPE LINER NEUT 58 LL X 36 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 62551661

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R