BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 NEUTRAL E1 LINER 32MM D

    MDR report key: 7374786 · Received March 27, 2018

    Report

    Report Number
    0001825034-2018-02091
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    March 2, 2018
    Report Date
    March 29, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED DURING SURGERY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MEDICAL DEVICES: ITEM # 010000848, LINER, LOT # 6142850; ITEM # 010000662, CUP, LOT # 6208312. MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-02090, 0001825034-2018-02091.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CAT # 010000848, G7 NEUTRAL E1 LINER 32MM D, LOT # 6142850 G7 PPS LTD ACETABULAR SHELL 50D CAT#: 010000662 LOT#:6208312. THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-02090, 0001825034-2018-02091.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PRIMARY SURGERY, MULTIPLE LINERS WOULD NOT SEAT PROPERLY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218271 G7 NEUTRAL E1 LINER 32MM D HIP PROSTHESIS PBI ZIMMER BIOMET, INC. N/A 6176995

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR