BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM IM STEM WITH SCREW

    MDR report key: 7428580 · Received April 13, 2018

    Report

    Report Number
    0001825034-2018-02576
    Event Type
    Injury
    Date Received
    April 13, 2018
    Date of Event
    March 6, 2018
    Report Date
    May 28, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK123501
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED BECAUSE THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 150395, LOT NUMBER - 862660, EXPIRATION DATE - DEC 2, 2015, UDI # - (B)(4). MANUFACTURE DATE ¿ DEC 2, 2015. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 150385, LOT NUMBER - 724750, EXPIRATION DATE - NOV 12, 2025, UDI # - (B)(4), MANUFACTURE DATE ¿ NOV 12, 2015. 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

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THE PATIENT WAS EXPERIENCING ASEPTIC LOOSENING OF THE STEM AND SEVERE PAIN PRIOR TO THE REVISION PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO STEM LOOSENING AND SUBSIDENCE WHICH LED TO A SHORTENED LEG LENGTH. THE SURGEON CEMENTED THE ORIGINAL FEMORAL COMPONENT INTO PLACE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: OSS TIBIAL BEARING, CATALOG #: 161096, LOT #: 395390. OSS YOKE SET, CATALOG #: CP116409, LOT #: 753320. OSS DISTAL FEMORAL COMPONENT, CATALOG #: CP116407, LOT #: 752420. OSS MODULAR TIBIAL COMPONENT, CATALOG #: CP116408, LOT #: 752690. OSS POROUS STEM, CATALOG #: 150395, LOT #: 862660. OSS POROUS STEM, CATALOG #: 150385, LOT #: 150385. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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: 0001825034-2017-04410, 0001825034-2018-02577.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO LEG LENGTH DISCREPANCY. THE POLYETHYLENE BEARING AND ASSEMBLY WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271578 ORTHOPEDIC SALVAGE SYSTEM IM STEM WITH SCREW PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 753570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE