BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 62H

    MDR report key: 7638397 · Received June 26, 2018

    Report

    Report Number
    0001825034-2018-04283
    Event Type
    Injury
    Date Received
    June 26, 2018
    Date of Event
    March 1, 2018
    Report Date
    June 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 010000866, G7 NEUTRAL E1 LINER 40MM H, 6100243. 010000749, G7 NEUTRAL ARCOMXL LNR 40MM H, 6130588. 010000668, G7 PPS LTD ACET SHELL 62H, 6081830. 51-107180, TPRLC 133 MP TYPE1 PPS HO 18.0, 6068815. 650-1058, CER BIOLOXD OPTION HD 40MM, 2907294. 650-1067, CER OPTION TYPE 1 TPR SLEVE +3, 2921000. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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: 0001825034-2018-02119.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL HIP ARTHROPLASTY, THE LINER WOULD NOT LOCK INTO PLACE. A NEW LINER WAS TRIED WITH THE INITIAL CUP, BUT STILL WOULD NOT LOCK. THE CUP WAS THEN REMOVED FROM THE PATIENT TO IMPLANT A NEW ONE. THE SECOND LINER LOCKED PROPERLY INTO THE NEW CUP. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480832 G7 PPS LTD ACET SHELL 62H HIP PROSTHESIS PBI ZIMMER BIOMET, INC. N/A 3836813

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention