BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE LOCKING SCREW

    MDR report key: 8764695 · Received July 5, 2019

    Report

    Report Number
    0001825034-2019-02897
    Event Type
    Injury
    Date Received
    July 5, 2019
    Date of Event
    June 25, 2019
    Report Date
    October 22, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IT IS UNKNOWN WHICH SCREW FRACTURED, THE FOLLOWING SECTIONS COULD NOT BE COMPLETED BECAUSE THE PART/LOT INFORMATION COULD BE: PROCODE : KWS. CAT: 180553 LOT: 061520 . UDI: (B)(4). STERILE EXPIRATION DATE: JUN 21, 2027. PMA/510K : K132239. DEVICE MANUFACTURE DATE : JUN 21, 2027. OR THE PART/LOT INFORMATION COULD BE: PROCODE : KWS. CAT: 180555 LOT: 018410 . STERILE EXPRIATION DATE: AUG 29, 2027. UDI: (B)(4). PMA/510K : K132239. DEVICE MANUFACTURE DATE : AUG 29, 2017. OR THE PART/LOT INFORMATION COULD BE: PROCODE : KWS . CAT: 180552 LOT 818080 . UDI: (B)(4). STERILE EXPRIATION DATE: AUG 16, 2027. PMA/510K : K132239. DEVICE MANUFACTURE DATE : AUG 16, 2017. OR THE PART/LOT INFORMATION COULD BE: PROCODE : PHX. CAT: 180550 LOT: 494290. UDI: (B)(4). STERILE EXPIRATION DATE: MAY 17, 2027 PMA/510K : K132239. DEVICE MANUFACTURE DATE: MAY 17, 2017. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN WHICH SCREW FRACTURED, THE FOLLOWING SECTIONS COULD NOT BE COMPLETED BECAUSE THE PART/LOT INFORMATION COULD BE: CAT: 180553 LOT: 061520 OR THE PART/LOT INFORMATION COULD BE: CAT: 180555 LOT: 018410. OR THE PART/LOT INFORMATION COULD BE: CAT: 180552 LOT 818080 OR THE PART/LOT INFORMATION COULD BE: CAT: 180550 LOT: 494290. CONCOMITANT MEDICAL PRODUCTS: COMP LK SCR 3.5HEX 4.75X30 ST CAT: 180553 LOT: 061520, VERSA-DIAL/COMP TI STD TAPER CAT: 118001 LOT: 179150, COMP RVS CNTRL 6.5X30MM ST/RST CAT: 115396 LOT: 112560, COMP LK SCR 3.5HEX 4.75X40 ST CAT: 180555 LOT: 018410, COMP LK SCR 3.5HEX 4.75X25 ST CAT: 180552 LOT 818080, COMP RVRS SHLDR GLNSP STD 36MM CAT: 115310 LOT: 595240, COMP RVS TRAY CO 44MM CAT: 115370 LOT: 187420, ARCOM XL 44-36 STD HMRL BRNG CAT: XL-115363 LOT: 145490, COMP PRIMARY STEM 15MM STD CAT: 113655 LOT: 399360, COMP RVRS SHDR GLEN BSPLT +HA CAT: 115330 LOT: 369540. 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. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION DUE TO SCREW FRACTURE AND SEPTIC INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558353 COMPREHENSIVE LOCKING SCREW SCREW, FIXATION HWC ZIMMER BIOMET, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R