BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 DUAL MOBILITY LINER 46MM G

    MDR report key: 8700155 · Received June 14, 2019

    Report

    Report Number
    0001825034-2019-02566
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    April 17, 2019
    Report Date
    September 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K150522
    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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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. 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 ADDITIONAL INFORMATION. DOB - UNKNOWN DATE IN (B)(6) 1962.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PATIENT IDENTIFIER: (B)(6). (B)(4). CONCOMITANT MEDICAL PRODUCTS: PART: UNK, UNK HEAD, LOT: UNK; PART: 110024465, G7 DUAL MOBILITY LINER 46MM G, LOT: 143090; PART: UNK, UNK STEM, LOT: UNK; PART: EP-200152, ACT ARTIC E1 HIP BRG 28X46MM, LOT: 726800; PART: 010000666, G7 PPS LTD ACET SHELL 58G, LOT: 6320695. REPORT SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: HEAD: 0001822565-2019-02464, 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
    494230 G7 DUAL MOBILITY LINER 46MM G PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 143090

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R