BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CER LNR 36MM F

    MDR report key: 20525497 · Received October 24, 2024

    Report

    Report Number
    3002806535-2024-00405
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    October 8, 2024
    Report Date
    December 19, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271052
    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. G7 BONEMASTER LTD ACET SHL 56F ITEM# 010000705 LOT# 7510280; BIOLOX OPTION TAPER SLEEVE STANDARD NECK ITEM# 6501066 LOT# 2019050376; BIOLOX DELTA CERAMIC HEAD ITEM# 6501057 LOT# 3137897; TAPERLOC COMPLETE PRIMARY FEMORA POROUS-BONEMASTER REDUCE DISTAL 15X150MM HIGH OFFSET TYPE 1 TAPER FOR CEMENTLESS USE ITEM# 51114150 LOT# 6994220. G2. REPORT SOURCE: 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED BUT PICTURES OF THE EXPLANTED PRODUCTS WERE PROVIDED. THE LINER IS STILL ASSEMBLED IN THE SHELL AND SHOWS SCRATCHES AND ON THE ARTICULATING SURFACE. AS THE RIM OF THE LINER IS FRACTURED, THE EVENT CAN BE CONFIRMED. THE HEAD SHOWS METAL TRANSFERS ON THE ARTICULATING SURFACE. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CAN BE CONFIRMED, BUT A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. 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 THE PATIENT HAD A HIP REPLACEMENT AND SUBSEQUENTLY, APPROXIMATELY 15 MONTHS POST IMPLANTATION, UNDERWENT A REVISION SURGERY DUE TO CERAMIC LINER CRACK. SURGEON THINKS POTENTIALLY DUE TO INCREASED ACTIVITY BY THE PATIENT AS HE IS A YOUNGER PATIENT AND ALSO LARGER SIZE. DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    DILIGENCE IS COMPLETED AND NO FURTHER INFORMATION ON THE REPORTED EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2561573 BIOLOX DELTA CER LNR 36MM F PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 3121201 00887868271052

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Hospitalization| R SEE H11 NARRATIVE.