BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPR SRS PROX BDY - SM 48MM

    MDR report key: 9199095 · Received October 16, 2019

    Report

    Report Number
    0001825034-2019-04692
    Event Type
    Injury
    Date Received
    October 16, 2019
    Date of Event
    September 19, 2019
    Report Date
    December 30, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    PMA / PMN Number
    K111746
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. 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

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT DATE OF BIRTH: UNKNOWN DATE IN 1977. CONCOMITANT MEDICAL PRODUCTS: COMP RVS HMRL TI TRAY 44MM CAT: 115340 LOT: 840600, COMPR SRS PROX BDY - SM 48MM CAT: 211215 LOT: 293830, COMP RVRS SHDR GLEN BSPLT +HA CAT: 115330 LOT: 246470, COMP RVS CNTRL SCR 6.5X35MM ST CAT: 115383 LOT: 710590, COMP LOCKING SCREW 4.75X30MM CAT: 180503 LOT: 045530, COMP LOCKING SCREW 4.75X30MM CAT: 180503 LOT: 045530, COMPR SRS IC SEG - 60MM CAT: 211225 LOT: 818050, ARCOM XL 44-36 RTNV+3 HMRL BRG CAT: XL-115365 LOT: 958990, COMPR SRS MOD RGX AUG ¿ LG CAT : 211229 LOT : 611790, VERSA-DIAL/COMP TI STD TAPER CAT: 118001 LOT: 709109, COMP RVRS SHLDR GLNSP +6 36MM CAT: 115316 LOT: 955840, COMPR SRS MOD STEM - 11X100MM CAT: 211263 LOT: 636950. FOREIGN REPORT SOURCE: (B)(6). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO IMPLANT FRACTURE AN UNKNOWN TIMEFRAME POST IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990662 COMPR SRS PROX BDY - SM 48MM SHOULDER, PROSTHESIS JDC ZIMMER BIOMET, INC. 293830

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R