BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD STD NK

    MDR report key: 6998686 · Received November 3, 2017

    Report

    Report Number
    0001825034-2017-09684
    Event Type
    Injury
    Date Received
    November 3, 2017
    Date of Event
    September 9, 2015
    Report Date
    May 11, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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

    CONCOMITANT MEDICAL PRODUCTS: PART AND LOT NUMBERS HAVE BEEN CONFIRMED WITH OPERATIVE REPORTS ITEM NUMBER: RD118850, ITEM NAME: M2A CUP, LOT NUMBER: 867680, ITEM NUMBER: 21-103204, ITEM NAME: FEMORAL STEM, LOT NUMBER: 860160, 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

    (B)(6). MULTIPLE MDRS WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2017 - 09682, 0001825034 - 2017 - 09683, 0001825034 - 2017 - 09683. PATIENT IS A BILATERAL PATIENT. IT IS UNKNOWN WHICH DEVICES WERE IMPLANTED ON WHICH SIDE. 11-173663 M2A 38MM MOD HD +3MM NK LOT 444190; 11-173662 M2A 38MM MOD HD STD NK LOT 429170. PATIENT IS A BILATERAL PATIENT AND THE OTHER SET OF CUP, FEMORAL, AND NECK WILL BE REPORTED ON (B)(6). IT IS UNKNOWN WHICH DEVICES WERE IMPLANTED ON WHICH SIDE. RD118850 M2A 38MMX50MM CUP LOT 163980; RD118850 M2A 38MMX50MM CUP LOT 857690; 21-103204 HA TAPERLOC POR FMRL 10X140 LOT 860160; 21-103204 HA TAPERLOC POR FMRL 10X140 LOT 163850; 11-173663 M2A 38MM MOD HD +3MM NK LOT 444190; 11-173662 M2A 38MM MOD HD STD NK LOT 429170. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION DUE TO ADVERSE TISSUE REACTION APPROXIMATELY ELEVEN YEARS POST-IMPLANTATION. THE HEAD COMPONENT WAS REMOVED AND REPLACED. OPERATIVE NOTES STATE THAT APPROXIMATELY 6 ML OF "SEROSANGUINEOUS OPAQUE" FLUID WITH LIGHT PARTICULAR DEBRIS WAS ASPIRATED FROM THE HIP. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    LEGAL COUNSEL REPORTS PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PATIENT ALLEGATIONS OF FRICTION AND WEAR BETWEEN THE FEMORAL HEAD AND CUP CAUSING LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO THE PATIENT BLOOD, TISSUE, AND BONE. AS A RESULT, THE PATIENT EXPERIENCED SEVERE PAIN, DISCOMFORT, AND INFLAMMATION IN AND AROUND THE IMPLANTS, SORENESS, DYSFUNCTION, LOSS OF RANGE OF MOTION, AND METALLOSIS. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780654 M2A 38MM MOD HD STD NK PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 444190

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R