BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANIUM SCREW LOW PROF 5X25MM

    MDR report key: 8373350 · Received February 27, 2019

    Report

    Report Number
    0001825034-2019-00866
    Event Type
    Injury
    Date Received
    February 27, 2019
    Date of Event
    November 11, 2016
    Report Date
    July 25, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K992119
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. CONTRIBUTING FACTORS ARE DEGENERATIVE JOINT DISEASE SECONDARY TO CHILDHOOD HIP DISEASE. PATIENT HAS SIGNIFICANT LIMITATION OF MOTION OF HER RIGHT HIP AND SEVERE PAIN ATTRIBUTED TO HISTORY OF MULTIPLE SURGERIES ON THE RIGHT HIP AS A CHILD. POOR BONE QUALITY AND PATIENT ANATOMY WITH EXTENSIVE DIFFICULTY PLACING COMPONENTS IN INITIAL SURGERY. 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

    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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE SECOND REVISION, THE PATIENT EXPERIENCING APPROXIMATELY 1000 ML OF BLOOD LOSS AND RECEIVED 225 ML AUTOLOGOUS RED BLOOD CELLS FROM CELL SAVER REINFUSED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: 162307 ¿ BI-METRIC FEMORAL STEM ¿ 966440; 11-173660 ¿ M2A MODULAR HEAD ¿ 430130; RD118856 ¿ M2A CUP ¿ 330980; 113846 - LOW PROFILE SCREW - 255104; 113847 - LOW PROFILE SCREW - 297849; 113845- LOW PROFILE SCREW - 454210. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. 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 - 2018 - 03391, 0001825034 - 2018 - 03392, 0001825034 - 2019- 00863, 0001825034 - 2019 - 00869, 0001825034 - 2019 - 00870, 0001825034 - 2019 - 00871.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A SECOND RIGHT HIP REVISION APPROXIMATELY 12 YEARS POST IMPLANTATION DUE TO PAIN, DISLOCATION, METALLOSIS, AND PAINFUL SHORTENED LEG. DURING THE SURGERY, THE FEMORAL STEM WAS NOTED TO HAVE EXTENSIVE AMOUNT OF PROXIMAL BONE LOSS RIDING HIGH IN THE SOFT TISSUES. LARGE COLLECTION OF SEROUS FLUID WAS FOUND ALONG WITH LOOSE RIM SCREWS. THE ACETABULAR CUP FOUND WITHIN THE SOFT TISSUES. EXTENSIVE METALLOSIS WAS FOUND AROUND THE ACETABULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168505 TITANIUM SCREW LOW PROF 5X25MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 426960

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R