BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL E1 LINER

    MDR report key: 7372720 · Received March 27, 2018

    Report

    Report Number
    0001825034-2018-02119
    Event Type
    Injury
    Date Received
    March 27, 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE IMPLANT BEING DISCARDED AT THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MEDICAL DEVICES: BIOMET G7 NEUTRAL ARCOMXL LNR 40MM H ITEM #: 010000749 LOT #: 6130588; BIOMET G7 PPS LTD ACET SHELL 62H ITEM #: 010000668 LOT #: 3836813; BIOMET G7 PPS LTD ACET SHELL 62H ITEM #: 010000668 LOT #: 6081830; BIOMET TPRLC 133 MP TYPE1 PPS HO 18.0 ITEM #: 51-107180 LOT #: 6068815; BIOMET CER BIOLOXD OPTION HD 40MM ITEM #: 650-1058 LOT #: 2907294; BIOMET CER OPTION TYPE 1 TPR SLEVE +3 ITEM #: 650-1067 LOT #: 2921000. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 02120.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    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
    215513 G7 NEUTRAL E1 LINER HIP PROSTHESIS PBI ZIMMER BIOMET, INC. N/A 6100243

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention