BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 36/+3.5, TAPER 12/14

    MDR report key: 20568423 · Received October 30, 2024

    Report

    Report Number
    0009613350-2024-00519
    Event Type
    Injury
    Date Received
    October 30, 2024
    Date of Event
    September 13, 2024
    Report Date
    February 4, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024430372
    PMA / PMN Number
    K192416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, G3, G6, H2, H3, H6, H11. NO PRODUCT WAS RETURNED TO THE POST MARKET SURVEILLANCE TEAM FOR EXAMINATION. HOWEVER, ONE IMAGE SHOWING IMPLANT LABELS OF THE REPORTED PRODUCT AND CONCOMITANT PRODUCTS WAS RECEIVED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. 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. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND INSTABILITY, LEADING TO THE EXPLANTATION OF THE ACETABULAR COMPONENT. HOWEVER, THE EXTENT TO WHICH THE FEMORAL HEAD MAY HAVE POTENTIALLY CONTRIBUTED TO THE REPORTED ISSUE REMAINS UNCLEAR. CONSEQUENTLY, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 0

    CMP- (B)(4). D10: ITEM # 00875706201, 62MM O.D. SIZE NN POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH NN LINERS, LOT # 62990432. ITEM # 00875201536, 36MM I.D. SIZE NN ELEVATED RIM LINER USE WITH 62MM O.D. SIZE NN SHELL, LOT # 64030543. ITEM # 2846, ALLOCLASIC STEM UNCEMENTED, LOT # 2801620. 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.

    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 PATIENT UNDERWENT HIP REVISION APPROXIMATELY 5 YEARS POST IMPLANTATION DUE TO PAIN AND INSTABILITY. THE ACETABULAR COMPONENT WAS EXPLANTED. THE SURGICAL TECHNIQUE OF THE PRODUCT WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167487 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 36/+3.5, TAPER 12/14 PROSTHESIS, HIPS LZO ZIMMER GMBH N/A 2990983 00889024430372

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Hospitalization| R SEE H11 NARRATIVE