BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLRY-HD LAT POR FMRL 11X160MM

    MDR report key: 8605526 · Received May 13, 2019

    Report

    Report Number
    0001825034-2019-02165
    Event Type
    Injury
    Date Received
    May 13, 2019
    Date of Event
    December 13, 2017
    Report Date
    May 13, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INITIAL/FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: M2A 38MMX48MM CUP PN RD118848, LN 375460; M2A 38MM MOD HD+6MM NK NO SKRT, PN 11-173664, LN 196230. 0001825034-2018-09274-3, 0001825034-2018-09273-3. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OP NOTES. REVIEW OF PRIMARY SURGERY'S OP-NOTES DETERMINED THAT THE PATIENT UNDERWENT A TOTAL LEFT HIP ARTHROPLASTY DUE TO DEGENERATIVE OSTEONECROSIS. A M2A 38MM X 48 POROUS CUP, M2A MODULAR HEAD 38MM, MALLORY HEAD POROUS COATED STEM 11.8 X 168MM WERE USED TO COMPLETE THE PROCEDURE. REVIEW OF REVISION SURGERY'S OP-NOTE CONFIRMED THE REPORTED EVENT. PATIENT UNDERWENT REVISION OF LEFT TOTAL HIP ARTHROPLASTY DUE TO PAIN, SYNOVITIS, PSEUDOTUMOR, ALVAR REACTION, AND ELEVATED COBALT CHROMIUM IONS. DURING THE PROCEDURE, SIGNIFICANT SINOVITIS EFFUSION WITHIN THE LEFT HIP JOINT AND ALVAR TYPE OF REACTION/ ASEPTIC LYMPHOCYTIC VASCULITIS ASSOCIATED LESION WAS OBSERVED. MILD CORROSION WAS NOTED ON THE TRUNNION. 1 LITRE BLOOD LOSS HAD OCCURRED DURING THE PROCEDURE. NO BLOOD TRANSFUSION NOTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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'S LEFT HIP WAS REVISED APPROX. 14 YEARS POST IMPLANTATION DUE TO PAIN, SYNOVITIS WITH PSEUDOTUMOR, ALVAR REACTION, ELEVATED METAL IONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399241 MLRY-HD LAT POR FMRL 11X160MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 872370

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R