BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CERAMIC FEM HD 36/0MM

    MDR report key: 19402953 · Received May 28, 2024

    Report

    Report Number
    3002806535-2024-00190
    Event Type
    Injury
    Date Received
    May 28, 2024
    Date of Event
    April 29, 2024
    Report Date
    July 5, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271175
    PMA / PMN Number
    K200959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D10 - ASSOCIATED MEDICAL DEVICES: TPRLC 133 MP TYPE1 BM HO 10.0; ITEM# 51-117100; LOT# 6886974, G7 NEUTRAL E1 LINER 36MM F; ITEM# 010000858; LOT# 7252593, G7 OSSEOTI 4 HOLE SHELL 56MM F; ITEM# 110010246; LOT# 7250824. G2 - FOREIGN: AUSTRALIA 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.

    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. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. RADIOGRAPHS WERE PROVIDED AND REVIEWED. NOT SUBMITTED TO MMI FOR ASSESSMENT AS THIS WOULD NOT ENHANCE THE INVESTIGATION. THE ALLEGATION IS RELATED TO PAIN/DISCOMFORT (NOT AN OBSERVABLE/CONFIRMABLE SYMPTOM ON IMAGING) RELATED TO INCREASED LEG LENGTH (FULL LENGTH LEG IMAGES NOT PROVIDED) AND OFFSET FROM INITIAL SURGERY. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY ONE YEAR AND NINE MONTHS POST IMPLANTATION DUE TO PAIN AND DISCOMFORT RELATED TO INCREASED LEG LENGTH, AND OFFSET FROM PRIMARY HIP SURGERY. THE FEMORAL STEM AND HEAD WERE EXCHANGED. 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
    624199 BIOLOX DELTA CERAMIC FEM HD 36/0MM HIP PROSTHESIS LZO BIOMET UK LTD. 3107667 00887868271175

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention| H SEE H11 NARRATIVE.