BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS MOD EXPANDABLE SZ20 SEG

    MDR report key: 8699712 · Received June 14, 2019

    Report

    Report Number
    0001825034-2019-02587
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    February 26, 2019
    Report Date
    February 25, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS : OSS AXLE; P/N: 150480, L/N: 478830, STRYKER BONE CEMENT; P/N: 6191-1-001, L/N: RFQ139, STRYKER BONE CEMENT; P/N: 6191-1-001, L/N: RFQ139, OSS NON-MOD TIB PLATE SHORT 75; P/N: 161042, L/N: 755500, CPS ANCHOR PLUG 14MM; P/N: 178404, L/N: 794540, CPS TRANSVERSE PIN 6PK 40MM; P/N: 178529, L/N: 400660, OSS POLY FEMORAL BUSHINGS 2PK; P/N: 150477, L/N: 067100, OSS TIBIAL POLY BEARING 12MM; P/N: 150410, L/N: 010460, OSS POLY LOCK PIN; P/N: 150478, L/N: 275680, OSS 7CM SEGMENTAL FEMORAL LT; P/N: 150355, L/N: 610950, CPS LG H F SPINDLE 12MM PC HA; P/N: 178504, L/N: 533050, CPS NUT CO-CR-MO ALLOY; P/N: 178512, L/N: 778690, CPS CENTERING SLEEVE 16MM; P/N: 178538, L/N: 367360, OSS REINFORCED YOKE; P/N: 150493, L/N: 478850, OSS POLY TIBIAL BUSHING; P/N: 150476, L/N: 499260, OSS MOD EXPANDABLE SZ20 SEG; P/N: CP111234, L/N: 840040. 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 · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. X-RAYS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. NO FINDINGS WERE AVAILABLE DUE TO POOR QUALITY. IT WAS CONFIRMED THE PATIENT EXPERIENCED METALLOSIS; HOWEVER, WE COULD NOT CONFIRM THE DEVICE FAILED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. IMPLANTED ON UNKNOWN DAY IN (B)(6) 2010. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT LIMB SALVAGE PROCEDURE. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION SURGERY TO REMOVE AN UNKNOWN ROD APPROXIMATELY 9 YEARS POST-IMPLANTATION DUE TO PAIN AND SWELLING. DURING THE REVISION BLACK TISSUE AROUND THE ROD WAS NOTED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492438 OSS MOD EXPANDABLE SZ20 SEG PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 840040

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| R