BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CUP

    MDR report key: 8312619 · Received February 6, 2019

    Report

    Report Number
    0001822565-2019-00465
    Event Type
    Injury
    Date Received
    February 6, 2019
    Date of Event
    May 30, 2018
    Report Date
    February 26, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    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

    CONCOMITANT MEDICAL PRODUCTS- UNKNOWN FEMORAL HEAD CATALOG#: NI LOT#: NI, UNKNOWN FEMORAL STEM CATALOG#: NI LOT#: NI, UNKNOWN ACETABULAR LINER CATALOG#: NI LOT#: NI. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    THERE IS NO ADDITIONAL INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. DOI:10.1016/J.ARTH.2018.05.046. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS PRODUCT LOCATION IS UNKNOWN. 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 IN A JOURNAL ARTICLE THAT THE PATIENT EXPERIENCED A HIP REVISION ON AN UNKNOWN DATE DUE TO MALPOSITIONING OF THE ACETABULAR CUP. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103134 UNKNOWN CUP PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R