BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACET REV SHELL 74 OD

    MDR report key: 10008064 · Received April 28, 2020

    Report

    Report Number
    3005751028-2020-00058
    Event Type
    Injury
    Date Received
    April 28, 2020
    Date of Event
    December 13, 2016
    Report Date
    April 28, 2020
    Manufacturer
    ZIMMER TMT
    Product Code
    JDI
    UDI-DI
    00889024310964
    PMA / PMN Number
    K050937
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3005751028 - 2020 - 00059. CONCOMITANT MEDICAL PRODUCT(S): UNK LINER; UNK STEM; STRYKER RESTORATION CUP 56 MM PART#1235-2-562 LOT#G5830067; STRYKER X3 SIZE 28/56 INSERT PART#1236-2-856 LOT#306413; CER OPTION TYPE 1 TPR SLEVE +6 PE 1 PART#650-1068 LOT#646880; DELTA CERAMIC OPTION HEAD DIA2 8 PART#650-1055 LOT#195030. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 3RD REVISION OP NOTES DATED (B)(6) 2016 DEMONSTRATED THAT THE PATIENT WAS REVISED DUE TO CUP LOOSENING. SAME BONE LOSS WAS IDENTIFIED AROUND FEMUR AND ACETABULUM AS WHAT WAS IDENTIFIED IN THE PREVIOUS SURGERY. ACETABULAR AUGMENT HAD LOST IT FIXATION TO THE BONE AND SPONTANEOUSLY DE-COUPLED FROM THE ACETABULAR COMPONENT. ACETABULAR COMPONENT WAS MOVING SLIGHTLY BUT WAS NOT GROSSLY LOOSE. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT AN ADDITIONAL LEFT HIP REVISION ARTHROPLASTY APPROXIMATELY 5 MONTHS AFTER THE PREVIOUS SURGERY DUE TO LOOSENING OF THE ACETABULAR COMPONENTS. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470868 ACET REV SHELL 74 OD PROSTHESIS, HIP JDI ZIMMER TMT NI 63316453 00889024310964

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R