BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X46MM

    MDR report key: 9097758 · Received September 20, 2019

    Report

    Report Number
    0001825034-2019-04212
    Event Type
    Injury
    Date Received
    September 20, 2019
    Date of Event
    April 17, 2019
    Report Date
    September 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K161190
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). (B)(4). CONCOMITANT MEDICAL PRODUCTS: PART: 110024465, G7 DUAL MOBILITY LINER 46MM G, LOT: 143090. PART: 6276-7-020, STRYKER RESTORATION STEM, LOT: CAXV91AC. PART: 6276-1-325, STRYKER RESTORATION CONE BODY, LOT: 66410402. PAT: 6260-9-328, STRYKER LFIT V40 FEMORAL HEAD, LOT: 68418602. PART: 010000666, G7 PPS LTD ACET SHELL 58G, LOT: 6320695. FOREIGN SOURCE: (B)(6). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. REVISION NOTES NOTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION WHICH OCCURED WHILE TURNING IN BED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MFR: 0001822565-2019-02464. 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: LINER: 0001825034-2019-02566.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED AND SUBSEQUENTLY WAS REVISED AGAIN APPROXIMATELY 2 WEEKS LATER DUE TO DISLOCATION. THE STEM, LINER AND HEAD WERE REVISED DURING THIS SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892908 ACT ARTIC E1 HIP BRG 28X46MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 726800

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R