BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM MOD HEAD COCR STD NECK

    MDR report key: 6228631 · Received January 6, 2017

    Report

    Report Number
    0001825034-2016-05491
    Event Type
    Injury
    Date Received
    January 6, 2017
    Date of Event
    December 5, 2016
    Report Date
    December 29, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWY
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. CONCOMITANT PRODUCTS: 16-116046 983620 RNGLC+ LTD HOLE SHELL SZ46.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: XL-108222 324920 ARCOMXL 32 MM +3 MROM LNR SZ 22, 16-116046 983620 RNGLC+ LTD HOLE SHELL SZ46, UNKNOWN STEM. 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. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTIONS ARE REQUIRED. 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

    PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY THREE MONTHS POST-IMPLANTATION DUE TO DISLOCATION. IT WAS REPORTED THE PATIENT HAD BEGUN WORK OUT ROUTINE PRIOR TO RECOMMENDED POST-OP PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12275 32MM MOD HEAD COCR STD NECK PROSTHESIS, HIP KWY BIOMET ORTHOPEDICS N/A 324920

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R