BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPR METAL IMPACTOR

    MDR report key: 18836317 · Received March 5, 2024

    Report

    Report Number
    0001825034-2024-00621
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    February 13, 2024
    Report Date
    June 19, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    UDI-DI
    00880304731516
    PMA / PMN Number
    K193373
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM# 110031869; LOT# 65754330, ITEM# 25-0901-27Y-G1; LOT# 443529, ITEM# 20-8090-004-01; LOT# 66594803, ITEM# 110040202; LOT# 65560707, ITEM# 110040300; LOT# 65612838, ITEM# 405883; LOT# 66510807, ITEM# 405889; LOT# 66421554, ITEM# 180550; LOT# 66447116, ITEM# 180550; LOT# 66501610, ITEM# 180550; LOT# 66509576, ITEM# 180552; LOT# 66338597, ITEM# 115396; LOT# 65903504, ITEM# 110032420; LOT#66300161, ITEM# 115310; LOT# J7672434, ITEM# 110031424; LOT# 66163756, ITEM# 110031399; LOT# 66469810, ITEM# 113614; LOT# 65664956. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6. VISUAL EXAMINATION OF THE PROVIDED PICTURE IDENTIFIED THE IMPACTOR TIP TO BE FRACTURED. NO THREAD DAMAGE IS PRESENT. FURTHERMORE, SCRATCHES ARE PRESENT ON THE SURFACE OF THE IMPACTOR. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS CONFIRMED, BASED ON EXAMINATION OF THE PROVIDED PHOTOS. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE IMPACTOR BROKE DURING SEATING OF THE IMPLANT. IT WAS NOTED THE DEVICE WAS OLDER AND BROKE UPON IMPACT. NO PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144926 COMPR METAL IMPACTOR SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ZIMMER BIOMET, INC. NI 484610 00880304731516

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female SEE NARRATIVE IN H10