BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM (OSS) SEGMENTAL ELLIPTICAL FEMORAL

    MDR report key: 8508706 · Received April 12, 2019

    Report

    Report Number
    0001825034-2019-01684
    Event Type
    Injury
    Date Received
    April 12, 2019
    Date of Event
    March 13, 2019
    Report Date
    December 13, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. UDI: (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. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 05321.

    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

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). 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. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE DUE TO BONE FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304755 ORTHOPEDIC SALVAGE SYSTEM (OSS) SEGMENTAL ELLIPTICAL FEMORAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 899890

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R