BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLRY-HD POR FMRL 12X165MM

    MDR report key: 7882419 · Received September 17, 2018

    Report

    Report Number
    0001825034-2018-08770
    Event Type
    Injury
    Date Received
    September 17, 2018
    Date of Event
    March 20, 2017
    Report Date
    November 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    N/A.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 157442, M2A-MAGNUM MOD HD SZ 42MM, LOT# 200260; ITEM# 139252, M2A-MAGNUM 42-50MM TPR INSRT-6 ,LOT# 407140; ITEM# US157848, M2A-MAGNUM PF CUP 48ODX42ID, LOT# 926780. 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: 0001825034-2018-08771, 0001825034-2018-08769, 0001825034-2018-08768.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY APPROXIMATELY 5 YEARS AGO. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 4 YEARS POST OP DUE TO PAIN. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723589 MLRY-HD POR FMRL 12X165MM PROSTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 787550

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R