BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW 6.5X35MM

    MDR report key: 7333790 · Received March 13, 2018

    Report

    Report Number
    0001825034-2018-01861
    Event Type
    Injury
    Date Received
    March 13, 2018
    Date of Event
    May 14, 2013
    Report Date
    May 7, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTIONS CONTAINED WITHIN THIS REPORT HAVE NO EFFECT ON PREVIOUS INVESTIGATION CONCLUSION. 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

    THE FOLLOW UP REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION RECEIVED. THE COMPLAINT WAS CONFIRMED BASED ON THE SURGICAL NOTES THAT WERE PROVIDED. DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND IDENTIFIED NO DEVIATIONS OR ANOMALIES RELEVANT TO THE REPORTED EVENT. A ROOT CAUSE CANNOT BE IDENTIFIED BASED ON THE INFORMATION AVAILABLE. 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). MEDICAL DEVICES: 11-300919, ARCOS 19X190MM SPL TPR DIST, 649370; 11-301344, ARCOS CON SZ D STD 80MM, 906930; 11-107023, FREEDOM CONSTR. LINER +5 SZ 24, 821570; 11-107021, FREEDOM CONSTR HD 36MM T1 +9MM, 273000; PM156556, PECK RT TFLANGE SZ24, 784760; 103538, TI LOW PROFILE SCREW 6.5X60MM, 644450; 103537, TI LOW PROFILE SCREW 6.5X50MM, 618190; 103537, TI LOW PROFILE SCREW 6.5X50MM, 618190; 103533, TI LOW PROFILE SCREW 6.5X30MM, 841500; 103533, TI LOW PROFILE SCREW 6.5X30MM, 405510; 103534, TI LOW PROFILE SCREW 6.5X35MM, 625050; 103534, TI LOW PROFILE SCREW 6.5X35MM, 863980; 103539, TI LOW PROFILE SCREW 6.5X70MM, 527170; 103535, TI LOW PROFILE SCREW 6.5X40MM, 864000; 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 - 01850; 0001825034 - 2018 - 01851; 0001825034 - 2018 - 01852; 0001825034 - 2018 - 01853; 0001825034 - 2018 - 01854; 0001825034 - 2018 - 01855; 0001825034 - 2018 - 01856; 0001825034 - 2018 - 01857; 0001825034 - 2018 - 01858; 0001825034 - 2018 - 01859; 0001825034 - 2018 - 01860; 0001825034 - 2018 - 01862; 0001825034 - 2018 - 01863; 0001825034 - 2018 - 01864; REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE DUE TO A RIGHT HIP INFECTION ONE MONTH POSTOPERATIVELY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176402 TI LOW PROFILE SCREW 6.5X35MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 388940

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R