BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LK SCR 3.5HEX 4.75X25 ST

    MDR report key: 14858934 · Received June 29, 2022

    Report

    Report Number
    0001825034-2022-01512
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    October 22, 2021
    Report Date
    August 9, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304677159
    PMA / PMN Number
    K130390
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01511, 0001825034-2022-01510 AND 0001825034-2022-01515. MEDICAL PRODUCTS: ITEM#: 115398, COMP RVS CNTRL 6.5X40MM ST/RST; LOT#: 941740, ITEM#: 180553, COMP LK SCR 3.5HEX 4.75X30 ST; LOT#: 044810, ITEM#: 180550, COMP LK SCR 3.5HEX 4.75X15 ST; LOT#: 296340, ITEM#: 12-113560, COMPR 10MM HUM FRACT STEM PPS; LOT#: 438080, ITEM#: 010000589, COMP RVRS 25MM BSPLT HA+ADPTR; LOT#: 010240, ITEM#: 115310, COMP RVRS SHLDR GLNSP STD 36MM; LOT#: 140920. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-01511-1 0001825034-2022-01510-1 0001825034-2022-01515-1 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 THE PATIENT UNDERWENT A TWO STAGE REVISION ARTHROPLASTY OF THE LEFT SHOULDER PROSTHESIS APPROXIMATELY 16 MONTHS POST REVISION ARTHROPLASTY DUE TO INFECTION, WHICH CAUSED LOOSENING OF THE SCREWS AND LED BONE LOSS OF THE GLENOID. THE PHYSICIAN FEELS THAT THE INFECTION STARTED AFTER THE INITIAL SURGERY AND THAT IT HAS REMAINED UNTIL THIS TWO STAGE REVISION WHEN THE INFECTION WAS TREATED. NO ADDITIONAL PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A TWO STAGE REVISION ARTHROPLASTY OF THE LEFT SHOULDER PROSTHESIS APPROXIMATELY SIXTEEN (16) MONTHS POST REVISION ARTHROPLASTY DUE TO INFECTION, WHICH CAUSED THE LOOSENING OF THE IMPLANT AND LED BONE LOSS OF THE GLENOID. DUE TO THIS, THE IMPLANT FRACTURED. THE PHYSICIAN FEELS THAT THE INFECTION STARTED AFTER THE INITIAL SURGERY AND THAT IT HAS REMAINED UNTIL THIS TWO STAGE REVISION WHEN THE INFECTION WAS TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923124 COMP LK SCR 3.5HEX 4.75X25 ST SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES KWS ZIMMER BIOMET, INC. 180552 453060 00880304677159

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H SEE H10 NARRATIVE