BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 PPS LTD ACET SHELL 54F

    MDR report key: 7188866 · Received January 15, 2018

    Report

    Report Number
    0001825034-2018-00050
    Event Type
    Injury
    Date Received
    January 15, 2018
    Date of Event
    December 20, 2017
    Report Date
    October 10, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE SHELLS FOUND NO DAMAGE TO THE LOCKING FEATURE OR DEFORMATION OF THE SCREW HOLES THAT WOULD PREVENT THE LINERS FROM SEATING PROPERLY. MINOR SCRATCHES WERE OBSERVED ON THE RIM AND INNER RADIUS OF THE SHELLS. THE SHELLS WERE SENT TO DIMENSIONAL ANALYSIS FOR FURTHER EVALUATION. THE DIMENSIONAL ANALYSIS FOR THIS DEVICE WAS FOUND TO BE WITHIN THE SPECIFICATIONS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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 · 1

    (B)(4). CONCOMITANT PRODUCT(S): A 010000936, G7 HI-WALL E1 LINER 36MM F, 6183586. A 010000858, G7 NEUTRAL E1 LINER 36MM F, 6134179. A 010000663, G7 PPS LTD ACET SHELL 52E, 6171900. A 010000857, G7 NEUTRAL E1 LINER 36MM E, 6130612. REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 00051, 0001825034 - 2018 - 00052, 0001825034 - 2018 - 00053, 0001825034 - 2018 - 00055.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PROCEDURE, THE SURGEON HAD DIFFICULTY INSERTING THE LINER INTO THE SHELL. IT WAS DECIDED TO USE A SECOND SHELL AND LINER; HOWEVER, THE SURGEON HAD DIFFICULTY INSERTING THE LINER. A THIRD LINER WAS USED WITH THE SECOND SHELL; THE SURGEON HAD DIFFICULTY INSERTING THE THIRD LINER. DIFFERENT CUP AND LINER WERE USED TO COMPLETE THE PROCEDURE. DURING IMPACTION OF THE LINERS, THE ACETABULUM WAS FRACTURED. THE PROCEDURE WAS DELAYED OVER 2 HOURS DUE TO THE DIFFICULTY INSERTING LINERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34229 G7 PPS LTD ACET SHELL 54F PROSTHESIS, HIP PBI ZIMMER BIOMET, INC. N/A 6149862

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R