BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHELL POROUS WITHOUT HOLES 54 MM O.D.

    MDR report key: 8507284 · Received April 11, 2019

    Report

    Report Number
    0002648920-2019-00249
    Event Type
    Injury
    Date Received
    April 11, 2019
    Date of Event
    November 10, 2017
    Report Date
    April 4, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K161830
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: SHELL POROUS WITHOUT HOLES 54 MM O.D. PN 00620005421 LN 61840614, 36MM COCR MOD HD -3MM, PN 11-363661, LN 422150, ECHO POR FMRL LAT NC 8X120MM, PN 192108, LN 507060. REPORT SOURCE: (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 THAT A PATIENT WAS REVISED DUE TO A WORN AND MALPOSITIONED HIP, APPROXIMATELY 5 YEARS AFTER THE INITIAL SURGERY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300211 SHELL POROUS WITHOUT HOLES 54 MM O.D. PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 61840614

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R