BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCOLOGY SALVAGE SYSTEM- CEMENTED IM STEM 9MMX90MM

    MDR report key: 6450826 · Received March 31, 2017

    Report

    Report Number
    0001825034-2017-02309
    Event Type
    Injury
    Date Received
    March 31, 2017
    Date of Event
    March 2, 2017
    Report Date
    October 5, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: OSS IM STEM 12X150 CATALOG 150366 LOT 693740. OSS MODULAR PROXIMAL TIBIA 9CM CATALOG 150493 LOT 801300. OSS REINFORCED YOKE CATALOG 150493 LOT 324820. OSS 3CM RESURFACING FEMUR CATALOG 150350 LOT 416570. OSS POLY TIBIAL BUSHING CATALOG 150476 LOT 669520. OSS POLY FEMORAL BUSHINGS, 2PK CATALOG 150477 LOT 626620. OSS TIBIAL POLY BEARING 12MM CATALOG 150410 LOT 970950. OSS POLY LOCK PIN CATALOG 150478 LOT 702690. OSS AXLE CATALOG 150480 LOT 050780. OSS POLY FEMORAL BUSHINGS 2PK CATALOG 150477 LOT 530620. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS RETAINED BY THE PATIENT. 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 FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST IMPLANTATION DUE TO A KNEE STEM FRACTURE. NO PATIENT TRAUMA WAS REPORTED TO HAVE BEEN ASSOCIATED WITH THE EVENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT ALLEGEDLY EXPERIENCED A FRACTURE SENSATION. APPROXIMATELY ONE MONTH THE LATER THE PATIENT UNDERWENT A REVISION PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233439 ONCOLOGY SALVAGE SYSTEM- CEMENTED IM STEM 9MMX90MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS 788790

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R