BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 ACETABULAR LINER

    MDR report key: 7173756 · Received January 8, 2018

    Report

    Report Number
    0001825034-2018-00007
    Event Type
    Injury
    Date Received
    January 8, 2018
    Date of Event
    November 11, 2017
    Report Date
    March 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE SUBMITTED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034 - 2018 - 00006, 0001825034 - 2018 - 00007, 0001825034 - 2018 - 00008, 0001825034 - 2018 - 00009. CONCOMITANT PRODUCT(S):- A 010000661 G7 PPS LTD ACET SHELL 48C LOT 6046909. A 010000847 G7 NEUTRAL E1 LINER 32MM C LOT 3433402. A 193008 ECHO B-MTRC MP FP SO 8 LOT 357360. 650-1056 CER BIOLOXD OPTION HD 32MM LOT 2887353. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    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 WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 THE PATIENT WAS ADMITTED TO ER FOUR DAYS POST-IMPLANTATION WITH REDNESS NEAR INCISION SITE. PATIENT WAS DIAGNOSED WITH HEMATOMA AND WAS SENT HOME WITHOUT CHANGE IN TREATMENT. HEMATOMA WAS REPORTED TO BE RESOLVED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14795 G7 ACETABULAR LINER PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER, + ADDITIVE PBI ZIMMER BIOMET, INC. N/A 3433402

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other