BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM I.D. SIZE F HIGH WALL LINER

    MDR report key: 20146987 · Received September 5, 2024

    Report

    Report Number
    0001822565-2024-02866
    Event Type
    Injury
    Date Received
    September 5, 2024
    Date of Event
    May 17, 2024
    Report Date
    September 6, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    0889024520493
    PMA / PMN Number
    K190660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CAT# 574102075 LOT# 3025550 FEMORAL STEM CEMENTLESS COLLARLESS HIGH OFFSET 12/14 TAPER SIZE 7.5 CAT# 010000665 LOT# 7061707 G7 PPS LTD ACET SHELL 56F CAT# 00877503602 LOT# 3085217 BIOLOX DELTA HEAD 12/14 36X0 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

    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. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT CANNOT BE CONFIRMED. 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 2 YEARS POST IMPLANTATION OF A LEFT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO AN UNKNOWN REASON. THE STEM WAS RETAINED, AND THE OTHER PRODUCTS WERE SCRAPPED. NO ADDITIONAL INFORMATION IS AVAILABLE

    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
    1865107 36MM I.D. SIZE F HIGH WALL LINER PROTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 65126802 0889024520493

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H