BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCOLOGY SALVAGE SYSTEM POLY FEMORAL BUSHINGS 2PK

    MDR report key: 6630620 · Received June 9, 2017

    Report

    Report Number
    0001825034-2017-03733
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    March 18, 2012
    Report Date
    November 2, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT(S) UPDATE: CATALOG #: 178554, CPS SHORT ANCHOR PLUG 12MM, LOT # 727370. CATALOG #: 178527, CPS TRANSVERSE PIN 6PK 32MM, LOT # 355690. CATALOG #: 178536, CPS CENTERING SLEEVE 14MM, LOT # 529260. CATALOG #: 178576, CPS SHRT 600# SM SPINDLE HA, LOT # 753300. CATALOG #: 178512, CPS NUT CO-CR-MO ALLOY, LOT # 275130 . CATALOG #: 178711, CPS/OSS 5CM TPR ADAPT W/OSS SC, LOT # 643140. CATALOG #: 150468, OSS 11CM DIAPHYSEAL SEGMENT, LOT # 203000. CATALOG #: 150466, S 7CM DIAHPYSEAL SEGMENT, LOT # 169290. CATALOG #: 150483, OSS SEGMENTAL STACKING ADAPTER, LOT # 509310. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE THE UNKNOWN LOCATION OF THE DEVICE. 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: 0001825034-2017-03727, 03733, 03735, 03736.

    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 WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 THAT PATIENT UNDERWENT A KNEE ARTHROPLASTY APPROXIMATELY 6 YEARS AGO. SUBSEQUENTLY, PATIENT UNDERWENT A WASHOUT WITH A POLY SWAP 6 MONTHS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412796 ONCOLOGY SALVAGE SYSTEM POLY FEMORAL BUSHINGS 2PK PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS 179540

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| R