BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS INTERLOK BOWED IM STEM WITH SCREW

    MDR report key: 9362751 · Received November 22, 2019

    Report

    Report Number
    0001825034-2019-05321
    Event Type
    Injury
    Date Received
    November 22, 2019
    Date of Event
    March 13, 2019
    Report Date
    December 13, 2019
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). CONCOMITANT MEDICAL PRODUCTS: OSS 7CM SEG ELLIPT FEMORAL LT; P/N: 150357, L/N 899890, OSS AXLE; P/N: 150480, L/N: 110030, OSS REINFORCED YOKE; P/N: 150493, L/N: 053560, INTRAMEDULLARY PLUG XL; P/N: 130615, L/N: 538740, OSS POLY FEMORAL BUSHINGS 2PK; P/N: 150477, L/N: 459710, OSS TIBIAL POLY BEARING 14MM; P/N: 150411, L/N: 002150, SERIES A PAT STD 37 3 PEG; P/N: 184768, L/N: 459740, OSS POLY TIBIAL BUSHING; P/N: 150476, L/N: 419390, INTRAMEDULLARY PLUG XL; P/N: 130615, L/N: 538740, OSS CEMENTED IM STEM 18X150; P/N: 150372, L/N: 513160, OSS POLY LOCK PIN; P/N: 150478, L/N: 617910. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 01684 - 1, 0001825034 - 2019 - 05321. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE DUE TO BONE FRACTURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160439 OSS INTERLOK BOWED IM STEM WITH SCREW PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 513160

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R