BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LINER

    MDR report key: 13181566 · Received January 6, 2022

    Report

    Report Number
    0001825034-2022-00061
    Event Type
    Injury
    Date Received
    January 6, 2022
    Date of Event
    December 13, 2021
    Report Date
    February 21, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K090103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (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. CONCOMITANT MEDICAL PRODUCTS: PART # 5 106022/ RINGLOC+ REPLACEMENT/ LOT # 295710, PART # 650-1056/ BIOLOXD OPTION HD / LOT # 3033039, PART # 650-1066 / TPRSLEVE/ LOT # 3053198. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-00062.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE ITEM AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE COULD NOT BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED AFTER EXPERIENCING ACUTE ONSET OF PAIN AND SQUEAKING. THE PAIN BECAME SO SEVERE OVER A WEEK THE PATIENT HAD TO USE CRUTCHES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED LINER WAS FRACTURED PRIOR TO REVISION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793343 UNKNOWN LINER PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10