BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CUP

    MDR report key: 7798362 · Received August 20, 2018

    Report

    Report Number
    0001825034-2018-08243
    Event Type
    Injury
    Date Received
    August 20, 2018
    Date of Event
    October 28, 2016
    Report Date
    October 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. SURGICAL NOTES FROM THE PATIENTS SECOND REVISION STATED THAT THERE WAS A MECHANICAL FAILURE OF THE RIGHT HIP TOTAL ARTHROPLASTY. INTRAOPERATIVE FINDINGS STATED THAT THE ACTIVE ARTICULATION BEARING HAD FRACTURED AND WRAPPED AROUND THE TRUNNION. THERE WAS A PERIPROSTHETIC FRACTURE OF THE GREATER TROCHANTER ALONG WITH SIGNIFICANT AMOUNT OF PSEUDOTUMOR FOUND ANTERIOR AND POSTERIORLY WITH SIGNIFICANT METAL STAINING DEBRIS AND METALLOSIS. SIGNIFICANT AMOUNT OF NECROTIC TISSUE WAS ALSO CLEARED FROM AROUND THE JOINT. IT WAS ALSO CONFIRMED THAT THE SHELL AND STEM WERE WELL FIXED, THEREFORE NO NEED FOR THEM TO BE REVISED. THE HEAD AND BEARING WERE REMOVED AND REPLACED, AND TWO CABLES AND A TROCHANTERIC CLAW WERE USED TO REDUCE THE FRACTURE. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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 · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 163660 ¿ MODULAR HEAD COMPONENT ¿ 212370, EP-200144 ¿ ACTIVE ARTICULATION E1 HIP BEARING ¿ 151650, UNKNOWN ITEM NUMBER - UNKNOWN STEM - UNKNOWN LOT NUMBER. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE LOCATION OF THE PRODUCT IS UNKNOWN. 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 -08240, 0001825034 -2018 -08241, 0001825034 - 2018 - 08303.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY 21 MONTHS POST IMPLANTATION DUE TO TROCHANTER FRACTURE, PSEUDOTUMOR, METALLOSIS, NECROSIS, AND ELEVATED METAL ION LEVELS. DURING THE PROCEDURE, IT WAS FOUND THAT THE STEM AND CUP COMPONENTS WERE STABLE, AND THE HEAD AND BEARING COMPONENTS NEEDED REVISED. A TROCHANTERIC CLAW AND CABLES WERE PLACED TO REPAIR THE TROCHANTER FRACTURE. 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
    638058 UNKNOWN CUP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 941440

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R