BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLIANCE X SERIES COLLARED INTEGRAL POROUS STEM

    MDR report key: 6652984 · Received June 20, 2017

    Report

    Report Number
    0001825034-2017-03835
    Event Type
    Injury
    Date Received
    June 20, 2017
    Date of Event
    June 2, 2017
    Report Date
    December 12, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030501
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF THE DHR FOUND NO DISCREPANCIES RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. RADIOGRAPHS WERE RECEIVED AND EVALUATED. X-RAY REVIEW NOTED, "ACETABULAR CUP IS LOCATED DEEP WITHIN THE ACETABULAR GROOVE AND ENCROACHES ON THE ILIOPECTINEAL LINE. METALLIC PLATES ON THE LEFT ISCHIAL SPINE SUGGEST THAT WAS TRAUMA PRIOR TO THE SURGERY. NO PRESENCE OF LUCENCIES AND BONE QUALITY APPEARS GOOD. POSSIBLE FACTORS FOR THE PROTRUSIO ARE CHRONIC OSTEOLYSIS IN THE REGION OF THE PLATE THAT COULD RESULT IN SLOW PROGRESSION OR PROTRUSIO MAY HAVE OCCURRED OVER TIME OR CUP IMPLANTED DEEPLY AS A RESULT OF PRIOR TRAUMA. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). CONCOMITANT PRODUCTS: M2A-MAGNUM PF CUP 60ODX54ID/ PN US157860/ LN 349690, ACT ARTIC E1 HIP BRG 28X54MM/ PN EP-200160/ LN 843540, 28MM DIA COCR MOD HD -3MM NK/ PN 163661/ LN 927810. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO IT BEING DISCARDED. 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 THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE DUE TO UNDERSIZED STEM APPROXIMATELY FIVE YEARS POST IMPLANTATION. SURGEON ALSO EXCHANGED HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433423 ALLIANCE X SERIES COLLARED INTEGRAL POROUS STEM PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 660390

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10