BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLORY HEAD 4-FIN, 3-HOLE CUP 56MM

    MDR report key: 7771783 · Received August 10, 2018

    Report

    Report Number
    0001825034-2018-08042
    Event Type
    Injury
    Date Received
    August 10, 2018
    Date of Event
    May 18, 2010
    Report Date
    October 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORTED EVENT WAS CONFIRMED FROM OPERATIVE NOTES RECEIVED. THE PRODUCT WAS NOT RETURNED FOR THE INVESTIGATION, THEREFORE A VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD WAS NOT REVIEWED DUE TO ITEM AND LOT IDENTIFICATION IS NECESSARY FOR REVIEW. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. 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)(4). CONCOMITANT DEVICES ¿ MICROPLASTY TAPERLOC STD 6 MM CATALOG #: NI LOT #: NI, BIOLOX DELTA 36 MM -3 NECK CATALOG #: NI LOT #: NI, E-POLY 36 MM RINGLOC MAX-ROM SIZE 24 CATALOG #: NI LOT #: NI. IT IS INDICATED BY THE COMPLAINANT THAT THE DEVICES 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: 0001825034-2018-08040, 0001825034-2018-08041, 0001825034-2018-08043.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PATELLAR DISLOCATION DURING HIP REDUCTION, WHICH WAS ATTRIBUTED TO THE TIGHTNESS OF THE IT BAND DUE TO LENGTHENING. A PIE CRUSTING OF THE IT BAND WAS PERFORMED, WHICH RELIEVED THE PRESSURE ON THE IT BAND. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614544 MALLORY HEAD 4-FIN, 3-HOLE CUP 56MM PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention