BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM SHELL

    MDR report key: 10301526 · Received July 21, 2020

    Report

    Report Number
    0001822565-2020-02618
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    June 28, 2020
    Report Date
    July 31, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K091508
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G4; H2; H6. REVISION PROCEDURE'S OPERATIVE NOTES WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING : THE SHELL WAS FOUND TO BE COMPLETELY DISLODGED, AND COULD BE EASILY REMOVED. THERE WAS NO BONY INGROWTH. THE CUP, SCREW, LINER, AND HEAD WERE REMOVED AND NEW PRODUCTS WERE IMPLANTED. NO OTHER COMPLICATIONS/ FINDINGS RELATED TO THE REPORTED EVENT WERE NOTED. THE ADDITIONAL INFORMATION RECEIVED DOES NOT CHANGE THE FINAL RESULTS OF PREVIOUS INVESTIGATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT MEDICAL PRODUCT: 00625006535 ¿ BONE SCREW ¿ UNKNOWN LOT. 00877504002 ¿ BIOLOX DELTA HEAD ¿ 231975. 00885101240 ¿ NEUTRAL LINER ¿ UNKNOWN LOT NUMBER. REPORTED EVENT IS CONFIRMED BY REVIEW OF MEDICAL RECORDS AND RADIOGRAPHS NOTING ACETABULAR COMPONENT SPINNING OUT OF POSITION AND A FRACTURED BONE SCREW. VISUAL REVIEW OF PHOTOGRAPHS IDENTIFIED THE FOLLOWING : THE PRODUCTS WERE COVERED IN BIODEBRIS. A FRAGMENT OF THE FRACTURED SCREW WAS PROTRUDING OUT OF ONE OF THE SCREW HOLES. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS UNABLE TO BE DETERMINED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2020 - 02619.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 9 YEARS POST IMPLANTATION DUE TO LOOSENING OF THE ACETUABULAR COMPONENT AND FRACTURE OF THE SCREW. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769658 CONTINUUM SHELL PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 61774203

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R SEE H10.