BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS 4 BOLT CONCENTRC CLMP

    MDR report key: 8125126 · Received December 3, 2018

    Report

    Report Number
    0001825034-2018-10801
    Event Type
    Injury
    Date Received
    December 3, 2018
    Date of Event
    April 16, 2018
    Report Date
    November 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    CUSTOM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. CONCOMITANT MEDICAL PRODUCTS: PART # XL-115366, ACROM XL 44-41 STD HMRL BRNG, LOT # 855090, PART # CP561425, CUST 15CM CPS/MOS INTERC, LOT # 991960, PART # 211218, COMPR SRS PROX BDY - LG , LOT # 539740, PART # 115370, COMP RVS TRAY CO 44MM, LOT 935350, PART # 115320, COMP RVRS SHLDR GLNSP STD 41MM, LOT # 600250, PART # CP111044, CPS CUST SHORT 10MM ANCHOR PLG, LOT # 763280, PART # 178525, CPS TRANSVERSE PIN 6PK 24MM, LOT # 094450, PART # 178526, CPS TRANSVERSE PIN 6PK 28MM, LOT # 823250, PART # CP112306, CUSTOM SHORT CPS SPINDLE, LOT # 377880, PART # 178512, CPS NUT CO-CR-MO ALLOY, LOT # 606520, PART # CP111171, CPS TIB SPINDLE 600LB WASH SET, LOT # 384810, PART # CP110351, COMPRESS 4 BOLT CONCENTRC CLMP, LOT # 365670. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 03400, 0001825034 - 2018 - 03401, 0001825034 - 2018 - 10802, 0001825034 - 2018 - 10803, 0001825034 - 2018 - 10804, 0001825034 - 2018 - 10805.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVERSE SHOULDER REVISION SURGERY. SUBSEQUENTLY, THE PATIENT EXPERIENCED DISLOCATION AND PERFORATION OF THE SKIN BY THE IMPLANT APPROXIMATELY TWO (2) YEARS POST-IMPLANTATION. PATIENT'S SHOULDER WAS INFECTED, AND DEVICES WERE REVISED. CURRENTLY, THE PATIENT HAS A TEMPORARY SPACER IN PLACE, AWAITING A CUSTOM REPLACEMENT PIECE FOR REVISION. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966886 COMPRESS 4 BOLT CONCENTRC CLMP PROSTHESIS, SHOULDER HSD ZIMMER BIOMET, INC. N/A 365670

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R