BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM TPR INSRT

    MDR report key: 8734323 · Received June 26, 2019

    Report

    Report Number
    0001825034-2019-02744
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    June 7, 2019
    Report Date
    November 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 (DHR) WAS REVIEWED AND NO DISCREPANCIES 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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING ELEVATED METAL ION LEVELS, INFLAMMATORY MARKERS QUITE ELEVATED. THERE IS SIGNIFICANT PURULENT MATERIAL AND PSEUDOTUMOR THAT WAS DEBRIDED ALONG WITH SCAR TISSUE. VISUAL INSPECTION FOUND THE TAPER TO BE HEAVILY DAMAGED AND DEFORMED. THE BOTTOM OF THE INSERT IS DINGED, GOUGED AND CUT SUCH THAT ONE OF THE CUTOUTS IS COMPLETELY MISSING. SCRATCHING IS PRESENT ON THE MAJORITY OF THE INSERT. THE INSERT WAS CUT STARTING FROM THE INSIDE OF THE NECK BUT DID NOT GO THROUGH THE ENTIRE THICKNESS. FOREIGN DEBRIS IS PRESENT INSIDE THE TAPER. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE RESULTS OF THE PREVIOUS INVESTIGATION. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT PRESENTED WITH PAIN, CLUNKING AND GRINDING, AND ELEVATED METAL ION LEVELS AND DISCUSSED WITH THE SURGEON ABOUT THE POSSIBILITY OF GETTING CULTURES IF THERE WAS SIGNIFICANT PURULENT APPEARING MATERIAL. THE PATIENT WENT IN FOR SURGERY APPROXIMATELY 9 YEARS POST IMPLANTATION WHERE PURULENT APPEARING FLUID WAS ENCOUNTERED, PSEUDOTUMOR IN THE TROCHANTERIC BURSA WAS DEBRIDED AND THE METAL HEAD WAS NOTED TO BE COLD WELDED TO THE STEM. THE HEAD COMPONENT WAS UNABLE TO BE REMOVED, SO THE SURGEON IRRIGATED AND SOAKED THE HIP IN BETADINE, REDUCED AND CLOSED IN LAYERS. THE PATIENT THEN RETURNED TO THE OPERATING ROOM APPROXIMATELY 2 MONTHS LATER. DURING THE SURGERY, THE HEAD COMPONENT WAS REMOVED WITH SIGNIFICANT EFFORT. THE CUP WAS RETROVERTED AND VERTICLE AND NEEDED TO BE MEDIALIZED TO OBTAIN A GOOD FIT. SURROUNDING OSTEOLYSIS WAS NOTED AND SIGNIFICANT POSTERIOR CAPSULE WAS LOST DUE TO DEBRIDEMENT. THERE WAS ALSO SCARRING OF THE SCIATIC NERVE THAT WAS DEBRIDED AS WELL. ATTEMPTS HAVE BEEN MADE, HOWEVER ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #US157854, MAGNUM CUP, LOT #831540; ITEM #11-104111, MALLORY HEAD, LOT #893820; ITEM #157448, MODULAR HEAD, LOT #143440. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICES REMAIN IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 -2019 -02743, 0001825034 -2019-02745, 0001825034 -2019-02746.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY APPROXIMATELY 9 YEARS POST OP THE PATIENT UNDERWENT A REVISION SURGERY DUE TO PAIN. IT WAS DISCOVERED DURING THIS SURGERY THE PATIENT HAD A SEVERE INFECTION. NO DEVICES WERE REMOVED. PATIENT IS BEING TREATED FOR THE INFECTION FOR 6 WEEKS, BEFORE ANOTHER REVISION SURGERY IS SCHEDULED. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530819 M2A-MAGNUM TPR INSRT HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 327230

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R