BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL ARCOMXL LNR 36MM H

    MDR report key: 7195098 · Received January 16, 2018

    Report

    Report Number
    0001825034-2018-00035
    Event Type
    Injury
    Date Received
    January 16, 2018
    Date of Event
    December 21, 2017
    Report Date
    April 10, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) CONCOMITANT MEDICAL PRODUCTS: 010000668, G7 PPS LTD ACET SHELL 62H, 3831312. THE 010000743, G7 NEUTRAL ARCOMXL LNR 36 MM H, 3912280. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. 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: 0001825034-2018-00034, 0001825034-2018-00033.

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE POLY LINER FOUND MULTIPLE TYPES OF DAMAGE CONSISTENT WITH ATTEMPTS TO IMPACT THE LINER INTO THE SHELL. FIVE (5) SCALLOPS ARE DEFORMED AND ARE NO LONGER FLUSH WITH THE PLANE OF LINER'S RIM. THIS DEFORMATION INDICATES THE LINER MAY NOT HAVE BEEN PROPERLY ALIGNED AT THE TIME OF IMPACTION. THE RIM OF THE LINER IS ALSO SCRATCHED AND GOUGED IN MULTIPLE LOCATIONS AS SEEN IN THE ATTACHED PHOTOS. THE OUTER RADIUS OF THE LINER IS FREE FROM ANY NOTICEABLE DAMAGE INDICATING IT DID NOT COME INTO CONTACT WITH ANY FOREIGN MATERIAL THAT WOULD NOT ALLOW IT TO SEAT APPROPRIATELY. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 LEFT HIP PROCEDURE THE LINER WOULD NOT SEAT IN THE SHELL. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT HIP PROCEDURE, THE LINER WOULD NOT SEAT IN THE ACETABULAR SHELL. A SECOND LINER WAS ATTEMPTED, WITH THE SAME RESULTS. THE CUP WAS REMOVED FROM THE PATIENT AND ANOTHER IMPLANT WAS UTILIZED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF APPROXIMATELY THIRTY (30) MINUTES AS A RESULT. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39552 G7 NEUTRAL ARCOMXL LNR 36MM H PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 3912280

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention