BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZB 12/14 COCR HD 36MM X +0

    MDR report key: 20567724 · Received October 30, 2024

    Report

    Report Number
    0001822565-2024-03426
    Event Type
    Injury
    Date Received
    October 30, 2024
    Date of Event
    October 17, 2024
    Report Date
    January 9, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024498884
    PMA / PMN Number
    K183457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT#: 110010243, LOT#: G7 OSSEOTI 3 HOLE SHELL 50MM D. CAT#: 00-6250-065-30, LOT#: J7356061 TRILOGY BONE SCR 6.5X30. CAT#: 01.06010.108, LOT#: 3151673 AVENIR MULLER STEM 8 LATERAL. CAT#: 010000934, LOT#: 7339289 G7 HI-WALL E1 LINER 36MM D. G2: FOREIGN: COUNTRY: AUSTRALIA. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6: COMPONENT CODE: MECHANICAL (G04) ¿ HEAD. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. UNABLE TO CONFIRM COMPLAINT BASED ON PROVIDED INFORMATION. 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 THAT APPROXIMATELY 11 MONTHS POST IMPLANTATION OF A RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO FOUR DISLOCATIONS WHICH OCCURRED ON UNSPECIFIED DATES. THE DISLOCATIONS WERE NOT RELATED TO FALLS. IT WAS REPORTED THAT THE PATIENT ARRIVED FOR THE REVISION SURGERY WALKING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1782188 ZB 12/14 COCR HD 36MM X +0 PROTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 2994091 00889024498884

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R