BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X15 ST

    MDR report key: 15624099 · Received October 18, 2022

    Report

    Report Number
    0001825034-2022-02333
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    February 17, 2022
    Report Date
    November 22, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304677135
    PMA / PMN Number
    K132239
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: COMP RVS CNTRL 6.5X30MM ST/RST CAT: 115396 LOT: 042450, COMP AUG MINI BSPLT W TPR MD CAT: 110032420 LOT: 64298726, COMP RVS TRAY CO 44MM CAT: 115370 LOT: 104620, ARCOM XL 44-36 STD HMRL BRNG CAT: XL-115363 LOT: 874890, COMP RVRS SHLDR GLNSP STD 36MM CAT: 115310 LOT: 502220, COMP LK SCR 3.5HEX 4.75X30 ST CAT: 180553 LOT: 530830. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01296, 0001825034-2022-00448, 0001825034 -2022 -02335. 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 REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED AN UNKNOWN BLACK OBJECT (2 PIECES) WAS RETURNED; IT WAS NOT GENERATED FROM THE OTHER RETURNED AND/OR REPORTED PRODUCTS AS THE COLOR DOES NOT MATCH THAT OF THE REPORTED PRODUCTS, AND COSMETIC INSPECTION OF THE RETURNED PRODUCTS FOUND ONLY LIGHT SCRATCHES AND WEAR MARKS. THE UNKNOWN FOREIGN BODY WAS SENT TO SEM FOR FURTHER ANALYSIS: EDS SEMI-QUANTITATIVE ELEMENTAL ANALYSIS OF AN UNKNOWN WIRE SAMPLE SHOWED THAT THE COMPOSITION WAS CONSISTENT WITH TI-6AL-4V MATERIAL, ALONG WITH O, C, P, AND S. THE WIRE APPEARED TO BE HEAVILY OXIDIZED AND CONTAMINATED WITH CARBON, PHOSPHOROUS AND SULFUR. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. IT IS POSSIBLE THAT THE UNKNOWN FOREIGN BODY WAS GENERATED DURING INSERTION OF THE SCREWS INTO THE BASEPLATE, HOWEVER THIS CANNOT BE CONFIRMED. ADDITIONALLY, IT IS UNKNOWN WHICH PRODUCT IT WAS POSSIBLY GENERATED FROM. IT REMAINS THAT A DEFINITIVE ROOT CAUSE CANNOT 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 · 0

    IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY 1 YEAR AND 2 DAYS POST IMPLANTATION DUE TO A FOREIGN OBJECT IDENTIFIED ON POST OP RADIOGRAPHS. THE OBJECT WAS REMOVED AND THE HUMERAL TRAY, HUMERAL BEARING , GLENOSPHERE AND MINI TAPER ADAPTER WERE ALL EXCHANGED FOR NEW IMPLANTS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2350662 COMP LK SCR 3.5HEX 4.75X15 ST SCREW, FIXATION KWS ZIMMER BIOMET, INC. N/A 509110 00880304677135

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Hospitalization| R