BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR LAT FMRL 9X137

    MDR report key: 6928799 · Received October 9, 2017

    Report

    Report Number
    0001825034-2017-08004
    Event Type
    Injury
    Date Received
    October 9, 2017
    Date of Event
    February 17, 2017
    Report Date
    October 5, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. CONCOMITANT MEDICAL PRODUCTS: 11-106052, R/B RLOC LHOLE SHL 52MM SZ 23, 394190; EP-108323, E-POLY 36MM +3 HIWALL LNR SZ23, 821420; 650-1057, CER BIOLOXD OPTION HD 36MM, 411390; 650-1064, CER OPTION TYPE 1 TPR SLEVE -6, 231850. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING A STEM REMOVAL PROCEDURE, THE SURGEON USED SOLID AND FLEXIBLE OSTEOTOMES TO DEBRIDE THE BONE IMPLANT INTERFACE AROUND THE PRESS-FIT FEMORAL STEM. HOWEVER, THE STEM COULD NOT BE DISENGAGED, RESULTING IN AN EXTENDED TROCHANTERIC OSTEOTOMY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711355 TAPERLOC POR LAT FMRL 9X137 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 172200

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R