BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCOLOGY SALVAGE SYSTEM

    MDR report key: 6395997 · Received March 10, 2017

    Report

    Report Number
    0001825034-2017-01514
    Event Type
    Injury
    Date Received
    March 10, 2017
    Date of Event
    January 31, 2017
    Report Date
    September 30, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ZIMMER BIOMET REFERENCE: (B)(4). CONCOMITANT MEDICAL PRODUCT: ITEM: ONCOLOGY SALVAGE SYSTEM STEM, ITEM NUMBER: 150376, LOT: 109260, ITEM: ONCOLOGY SALVAGE SYSTEM STEM, ITEM NUMBER: 150364, LOT: 618620, ITEM: ONCOLOGY SALVAGE SYSTEM MODULAR TIB BASE, ITEM NUMBER: 150422, LOT: 250040, ITEM: ONCOLOGY SALVAGE SYSTEM AXLE, ITEM NUMBER: 150480, LOT: 350830, ITEM: ONCOLOGY SALVAGE SYSTEM TIBIAL BEARING, ITEM NUMBER: 150412, LOT: 795550, ITEM: ONCOLOGY SALVAGE SYSTEM FEMORAL BUSHING, ITEM NUMBER: 150477, LOT: 231550, ITEM: ONCOLOGY SALVAGE SYSTEM REINFORCED YOKE, ITEM NUMBER: 150493, LOT: 141110, ITEM: ONCOLOGY SALVAGE SYSTEM POLY TIBIAL BUSHING, ITEM NUMBER: 150476, LOT: 161350, ITEM: ONCOLOGY SALVAGE SYSTEM POLY LOCK PIN, ITEM NUMBER: 150478, LOT: 141290, ITEM: OPTIVAC TOTAL HIP KIT, ITEM NUMBER: 417000, LOT: 0000747093, ITEM: COBALT G-HV BONE CEMENT, ITEM NUMBER: 402283, LOT: 627260, ITEM: COBALT G-HV BONE CEMENT, ITEM NUMBER: 402283, LOT: 627260. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-01513.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS EVALUATED, BUT THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-01513 / 07666.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A REVISION OF AN ONCOLOGY SALVAGE SYSTEM KNEE 4 YEARS POST IMPLANT, DUE TO FEMORAL LOOSENING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177388 ONCOLOGY SALVAGE SYSTEM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS 008970

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R