BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS MOD STEM - 16X75MM

    MDR report key: 7232468 · Received January 31, 2018

    Report

    Report Number
    0001825034-2018-00613
    Event Type
    Injury
    Date Received
    January 31, 2018
    Date of Event
    July 28, 2014
    Report Date
    February 6, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    PK111746
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE ALSO SEE ASSOCIATED REPORT(S): 0001825034 - 2018 - 00610, 0001825034 - 2018 - 00611, 0001825034 - 2018 - 00612, 0001825034 - 2018 - 00614, 0001825034 - 2018 - 00615, 0001825034 - 2018 - 00616, 0001825034 - 2018 - 00617, 0001825034 - 2018 - 00618, 0001825034 - 2018 - 00619, 0001825034 - 2018 - 00620. CONCOMITANT PRODUCT(S): A 010000589 COMP RVRS 25MM BSPLT HA+ADPTR LOT 696840. A 115323 COMP RVSR SHLDR GLNSP +3 41MM LOT 078060. A 115370 COMP RVS TRAY CO 44MM LOT 284420. A 211218 COMPR SRS PROX BDY - LG 42MM LOT 497840. XL-115366 ACROM XL 44-41 STD HMRL BRNG LOT 461380. XL-115368 ARCOM XL 44-41 RTNV +3 HMRL BR LOT 337820. A 115396 COMP RVS CNTRL 6.5X30MM ST/RST LOT 159850. A 115383 COMP RVS CNTRL SCR 6.5X35MM ST LOT 976250. A 180552 COMP LK SCR 3.5HEX 4.75X25 ST LOT 026950. A 180550 COMP LK SCR 3.5HEX 4.75X15 ST LOT 532120. A 180551 COMP LK SCR 3.5HEX 4.75X20 ST LOT 900380. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED 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 · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74365 COMPR SRS MOD STEM - 16X75MM PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. N/A 636570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R