BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC STEM

    MDR report key: 7753439 · Received August 6, 2018

    Report

    Report Number
    0001825034-2018-06118
    Event Type
    Injury
    Date Received
    August 6, 2018
    Date of Event
    July 8, 2013
    Report Date
    October 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK110400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - G7 PPS LTD ACET SHELL 52E # ITEM 010000663 LOT 2804310, G7 NEUTRAL E1 LINER 36MM E # ITEM 010000857 LOT 2921390, CER BIOLOXD OPTION HD 36MM # ITEM 650-1057 LOT 773770, CER OPTION TYPE 1 TPR SLEVE -3 # ITEM 650-1065 LOT 683160. X-RAY REVIEW REVEALED MASSIVELY DISPLACED AND CHRONIC PERIPROSTHETIC FRACTURE WITH A GROSSLY LOOSE STEM. 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 · 1

    IT WAS REPORTED A PATIENT UNDERWENT REVISION SURGERY THREE MONTHS POST INITIAL SURGERY DUE TO PERIPROSTHETIC FEMUR FRACTURE WITH GROSSLY LOOSE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593687 TAPERLOC STEM PROSTHESIS HIP KWA ZIMMER BIOMET, INC. 2479105

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R