BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER FEM HD 32/+3MM T1

    MDR report key: 18777131 · Received February 26, 2024

    Report

    Report Number
    3002806535-2024-00076
    Event Type
    Injury
    Date Received
    February 26, 2024
    Date of Event
    January 5, 2024
    Report Date
    April 18, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    K200959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. A REVIEW OF THE RAW MATERIAL CERTIFICATE CONFIRMED NO ABNORMALITIES OR DEVIATIONS. A REVIEW OF THE STERILIZATION CERTIFICATE CONFIRMED NO ABNORMALITIES OR DEVIATIONS. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ASSOCIATED MEDICAL DEVICES: CONTINUUM TM SHELL MULTI 56 KK; ITEM# 00-8757-056-02; LOT# 63494012. VIT E LINER NEUTRAL KK 32; ITEM# 00-8851-012-32; LOT# 63306634. TRILOGY BONE SCR 6.5X20; ITEM# 00-6250-065-20; LOT# 63480615. TRILOGY BONE SCR 6.5X20; ITEM# 00-6250-065-20; LOT# 63506572. TPRLC XR MP TYPE1 PPS 4.0; ITEM# 51-145040; LOT# 2931541. G2 - FOREIGN: JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY SIX YEARS AND SIX MONTHS POST INITIAL IMPLANTATION, THE PATIENT UNDERWENT A LEFT SIDED HIP REVISION DUE TO PAIN AND OSTEOLYSIS. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO FURTHER ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2255095 DELTA CER FEM HD 32/+3MM T1 HIP PROSTHESIS LZO BIOMET UK LTD. 2016051482

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Hospitalization| R