BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCOLOGY SALVAGE SYSTEM- OSS CEMENTED IM STEM 9MMX90MM

    MDR report key: 6672620 · Received June 28, 2017

    Report

    Report Number
    0001825034-2017-04349
    Event Type
    Injury
    Date Received
    June 28, 2017
    Date of Event
    March 2, 2017
    Report Date
    September 15, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS - OSS CEMENTED IM STEM, CATALOG #: 150366, LOT #: 693740; OSS POLY FEMORAL BUSHINGS 2 PK, CATALOG #: 150477, LOT #:626620; OSS POLY TIBIAL BUSHING, CATALOG #: 150476, LOT #: 669520; OSS AXLE, CATALOG #: 150480, LOT #: 050780; OSS TIBIAL POLY BEARING 12 MM, CATALOG #: 150410, LOT #: 970950; OSS REINFORCED YOKE, CATALOG #: 150493, LOT #: 324820; OSS POLY LOCK PIN, CATALOG #: 150478, LOT #: 702690; OSS MOD PROX TIB 9 CM, CATALOG #: 150443, LOT #: 801300; OSS 3 CM RESURFACING FEMORAL, CATALOG #: 150350, LOT #: 416570. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE REPORTED FOR THIS EVENT: 0001825034-2017-04346. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THIS REPORT IS A DUPLICATE OF MFR NUMBER 0001825034-2017-02309. THIS REPORT SHOULD BE VOIDED.

    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 LATER THE PATIENT UNDERWENT A REVISION PROCEDURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454050 ONCOLOGY SALVAGE SYSTEM- OSS CEMENTED IM STEM 9MMX90MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS 788790

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R