BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW 6.5X40MM

    MDR report key: 7299999 · Received February 27, 2018

    Report

    Report Number
    0001825034-2018-01537
    Event Type
    Injury
    Date Received
    February 27, 2018
    Date of Event
    January 29, 2018
    Report Date
    March 29, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    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: 163662, 28MM MOD HD STD NECK TP1 TAPER, 936320, EP-105885, EPOLY 28MM RLC LNR MROM SZ25, 243240, PM157199, VANDUYNE RIGHT TRIFLANGE SZ 25, 998540, 123741, 3/8-24 APICAL HOLE PLUG 1/CUP, 005980, 103532, TI LOW PROFILE SCREW 6.5X25MM, 991100, 103533, TI LOW PROFILE SCREW 6.5X30MM, 016760, 103533, TI LOW PROFILE SCREW 6.5X30MM, 196400, 103534, TI LOW PROFILE SCREW 6.5X35MM, 196470, 103536, TI LOW PROFILE SCREW 6.5X45MM, 247720, 103539, TI LOW PROFILE SCREW 6.5X70MM, 388660, 103535, TI LOW PROFILE SCREW 6.5X40MM, 298180, 103535, TI LOW PROFILE SCREW 6.5X40MM, 387710, 103535, TI LOW PROFILE SCREW 6.5X40MM, 530910, 103535, TI LOW PROFILE SCREW 6.5X40MM, 796820. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 - 00875, 0001825034 - 2018 - 00876, 0001825034 - 2018 - 00877, 0001825034 - 2018 - 01531, 0001825034 - 2018 - 01532, 0001825034 - 2018 - 01533, 0001825034 - 2018 - 01534, 0001825034 - 2018 - 01535, 0001825034 - 2018 - 01536, 0001825034 - 2018 - 01537, 0001825034 - 2018 - 01538, 0001825034 - 2018 - 01539, 0001825034 - 2018 - 01540.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IT IS UNCLEAR WHICH SCREWS WERE REVISED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE REVISION OP NOTES. OP NOTES INDICATED THE REMOVAL OF A FEW BROKEN SCREW HEADS. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE OF THE TRIFLANGE LOOSENING IS ATTRIBUTED TO PATIENT BONE QUALITY PER THE SURGEON. ROOT CAUSE FOR THE DISLOCATION AND SCREW FRACTURE 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

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO AN UNSTABLE AND DISLOCATING HIP. DURING THE PROCEDURE, IT WAS FOUND THE ACETABULAR SCREWS WERE FRACTURED AND THE CUP WAS LOOSE. THE HEAD, LINER, AND CUP WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143156 TI LOW PROFILE SCREW 6.5X40MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 530910

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R