BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHLDR GLNSP STD 36MM

    MDR report key: 8221687 · Received January 7, 2019

    Report

    Report Number
    0001825034-2018-11413
    Event Type
    Injury
    Date Received
    January 7, 2019
    Date of Event
    June 8, 2016
    Report Date
    April 11, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    K080642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. NO DEVICES, PHOTOS, OR MEDICAL RECORDS WERE RECEIVED FOR THIS EVENT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED, HOWEVER, IT SHOULD BE NOTED THAT THIS PATIENT IS A RANCHER WHO NEVER STOPPED WORKING, AND COULD CONTRIBUTE TO THE ISSUES. 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT DEVICE CODE - PHX. (B)(4). CONCOMITANT MEDICAL PRODUCTS: CP560865, 3.5X30MM BONE SCREW, LOT 699380; CP560869, 3.5X50 MM BONE SCREW, LOT 699420; 103533, 6.5X30 MM LOW PROFILE SCREW, LOT 348740; 113862, 5X30 MM LOW PROFILE SCREW, LOT 517310; CP560867, 3.5X40 MM BONE SCREW, LOT 699400; CP560863, 3.5X20 MM BONE SCREW, LOT 742010; CP560864, 3.5X25 MM BONE SCREW, LOT 699370; CP560866, 3.5X35 MM BONE SCREW, LOT 699390; CP560861, 3.5X10 MM BONE SCREW, LOT 699340; XL-115363, ARCOM XL 44-36 STD HMRL BRNG, LOT 386490; 115370, COMP RVS TRAY, LOT 648710; 115310, COMP RVRS SHLDR GLNSP, LOT 594180; 118001, TAPER, LOT 388050; 180552, SCREW, LOT 612100; 180552, SCREW, LOT 938320; 180553, SCREW, LOT 425770; 180551, SCREW, LOT 748420; 115397, COMP RVS CCNTRL 6.5X35MM ST/RST, LOT 193820; PM555334, LT PM RVS GLEN, LOT 429540; 211219, COMPR SRS PROX BDY, LOT 652520; 211218, COMP SRS PROX BDY, LOT 539740. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-01159.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 4 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION DUE TO DISLOCATION AND INSTABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14948 COMP RVRS SHLDR GLNSP STD 36MM PROSTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 594180

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R