BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM M2A MOD HEAD STD NK

    MDR report key: 6895466 · Received September 26, 2017

    Report

    Report Number
    0001825034-2017-07235
    Event Type
    Injury
    Date Received
    September 26, 2017
    Date of Event
    August 29, 2017
    Report Date
    October 19, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDL
    PMA / PMN Number
    PK042841
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR¿S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001822565-2017-06586. CONCOMITANT MEDICAL PRODUCTS: 103532 TI LOW PROFILE SCREW 6.5X25MM, L/N 900440; 15-103684 M2A-T UNIV 2-HOLE SHL SZ 41/54, L/N 074300; 103534 TI LOW PROFILE SCREW 6.5X35MM, L/N 230630; 13-103209 TAPERLOC POR RED/LAT 17.5X155, L/N 650940; 15-105004 M2A-TAPER LINER SZ 41/32, L/N 809170; 11-163669 32MM M2A MOD HEAD STD NK, L/N 175650. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. DEVICE HISTORY RECORD 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.

    Description of Event or Problem · 1

    IT WAS REPORTED A HIP REVISION OCCURRED DUE TO PATIENT PREFERENCE. THE PATIENT REPORTED NON-SPECIFIC SYMPTOMS SUCH AS NOT SLEEPING AND FELT IT WAS THE METAL ON METAL BEARING ARTICULATION CAUSING THE PROBLEMS. THE METAL LINER AND FEMORAL HEAD WERE REMOVED AND REPLACED WITH A POLY LINER AND NEW FEMORAL HEAD. NO DELAY TO SURGERY OR ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674589 32MM M2A MOD HEAD STD NK PROSTHESIS, HIP JDL ZIMMER BIOMET, INC. N/A 175650

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R