BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FEMORAL STEM

    MDR report key: 8320976 · Received February 8, 2019

    Report

    Report Number
    0001822565-2019-00558
    Event Type
    Injury
    Date Received
    February 8, 2019
    Report Date
    March 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THERE IS NO FAILURE ALLEGED AGAINST THE DEVICE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THERE IS NO FAILURE ALLEGED AGAINST THE DEVICE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNK ITEM, UNKNOWN FEMORAL HEAD, UNK LOT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, LOCATION OF PRODUCT IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. KWON, Y., ROSSI, D., MACAULIFFE, J., PENG, Y., & ARAUZ, P. (2018). RISK FACTORS ASSOCIATED WITH EARLY COMPLICATIONS OF REVISION SURGERY FOR HEAD-NECK TAPER CORROSION IN METAL-ON-POLYETHYLENE TOTAL HIP ARTHROPLASTY. THE JOURNAL OF ARTHROPLASTY, 33 (10), 3231-3237. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORTS: 0001822565-2019-00557.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE ONE PATIENT WAS REVISED FOR SYMPTOMATIC ADVERSE LOCAL TISSUE REACTION AND ELEVATED ION LEVELS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114804 UNKNOWN FEMORAL STEM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R