BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTRAL LINER 36 MM I.D. SIZE KK FOR USE WITH 56 MM O.D. SIZE KK SHELL

    MDR report key: 8741611 · Received June 27, 2019

    Report

    Report Number
    0001822565-2019-02660
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    January 8, 2019
    Report Date
    January 31, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K151448
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MODEL #:(01)00889024149199(17)220930(10)63785461. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D11: ZIMMER CONTINUUM TRILOGY LONGEVITY LINER, CAT. NO. 00-8751-012-36, LOT NO. 63785461. ZIMMER BIOLOX DELTA CERAMIC HEAD, CAT. NO. 00-8775-036-02, LOT NO. 2898804. ZIMMER WAGNER SL REVISION HIP STEM, CAT. NO. 01.00102.618, LOT NO. 2860005.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT WAS REVISED ONE YEAR POST-IMPLANTATION FOR UNKNOWN REASONS. HEAD AND LINER WERE REPLACED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM#: UNKNOWN, UNKNOWN CUP, LOT#: UNKNOWN. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT 2ND REVISION SURGERY APPROXIMATELY ONE YEAR AFTER THE FIRST REVISION, DUE TO UNKNOWN REASON. LINER AND HEAD REVISED PER INVOICE. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532183 NEUTRAL LINER 36 MM I.D. SIZE KK FOR USE WITH 56 MM O.D. SIZE KK SHELL PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 63785461

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R