BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLRY-HD LAT POR FMRL 12X165MM

    MDR report key: 11246044 · Received January 28, 2021

    Report

    Report Number
    0001825034-2021-00283
    Event Type
    Injury
    Date Received
    January 28, 2021
    Date of Event
    November 9, 2015
    Report Date
    January 28, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS CONFIRMED VIA OPERATIVE NOTES REVIEWED BY A HEALTH CARE PROFESSIONAL. SEM ANALYSIS IDENTIFIED: THE TAPER OF THE RETURNED DEVICE WAS REVIEWED VIA OPTICAL MICROSCOPY RESULTING IN A CONSENSUS MODIFIED GOLDBERG SCORE OF 4. A SCORE OF 4 CORRESPONDS TO, DAMAGE OVER THE MAJORITY (>50%) OF THE SURFACE WITH SEVERE CORROSION ATTACK AND ABUNDANT CORROSION DEBRIS. REVIEW OF COMPLAINT HISTORY FOR ITEM# 11-104212 LOT# 213430 IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM(S) AND PART AND LOT COMBINATION(S). COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW (REFERENCE (B)(4) AND (B)(4)) IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. ROOT CAUSE OF THE EVENT COULD NOT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP REVISION PROCEDURE APPROXIMATELY ELEVEN YEARS¿ POST-IMPLANTATION DUE TO PAIN AND METALLOSIS WAS NOTED DURING THE PROCEDURE. THE MEDICAL RECORDS STATE: THE COMPONENT WAS SLIGHTLY RETROVERTED WITH A PROMINENT ANTERIOR FLANGE WHICH MAY HAVE CAUSED SOFT TISSUE IRRITATION AND MAY HAVE BEEN THE SOURCE OF GROIN PAIN. THERE WERE NO COMPLICATIONS. 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
    142858 MLRY-HD LAT POR FMRL 12X165MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 213430

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R