BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC MICROPLASTY FEMORAL STEM

    MDR report key: 7762299 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-06774
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    October 7, 2016
    Report Date
    September 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK110400
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF REVISION OPERATIVE REPORTS AND X-RAYS RECEIVED. THE REVISION OPERATIVE REPORT STATED THE PATIENT PRESENTED WITH ONGOING PAIN. X-RAYS REVEALED MILD SUBSIDENCE, BUT GROSSLY ASEPTIC FIBROUS INGROWN FEMORAL COMPONENT. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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: 650-1064 ¿ CER OPTION TYPE 1 TPR SLEVE -6 ¿ 073530, 650-1057 ¿ CER BIOLOXD OPTION HD 36MM ¿ 924220. THERAPY DATE: (B)(6) 2016. 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

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY 6 MONTHS POST IMPLANTATION DUE TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. 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
    604241 TAPERLOC MICROPLASTY FEMORAL STEM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 3692860

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R