BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA OPTION CERAMIC HEAD 36MM

    MDR report key: 18146716 · Received November 16, 2023

    Report

    Report Number
    3002806535-2023-00387
    Event Type
    Injury
    Date Received
    November 16, 2023
    Report Date
    May 28, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271397
    PMA / PMN Number
    K082996
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL PRODUCT: ITEM#:650-1068 ;LOT#:2965056 ;ITEM NAME: CER OPTION TYPE 1 TPR SLEVE +6 ; D10 - THERAPY DATE: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535 - 2023 - 00388. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. 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 AND CORRECTED INFORMATION. D10: 110010247, G7 OSSEOTI 4 HOLE SHELL,58MM G, LOT # 6630992. 30103607, 36MM I.D. SIZE G NEUTRAL LINER, LOT # 64358597. 51-103140, TPRLC 133 T1 PPS SO 14X148MM, LOT # 6626648. FURTHER INVESTIGATED FOLLOWING RECEIPT OF XRAYS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: ACETABULI PROTRUSIO OF THE ACETABULAR COMPONENT WITH SUBSIDENCE OF THE FEMORAL COMPONENT AND DISLOCATION OF THE FEMORAL HEAD. FRACTURE SUPEROMEDIAL AND ANTERIOR ACETABULUM. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IT IS UNKNOWN WHICH OF THE EVENTS (DISLOCATION, STEM SUBSIDENCE, OR SHELL LOOSENING) OCCURRED FIRST. 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR REVISION SURGERY ON AN UNKNOWN DATE, DUE TO UNKNOWN REASONS. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT HIP ARTHROPLASTY ON AN UNKNOWN DATE. THE PATIENT IS BEING CONSIDERED FOR REVISION SURGERY ON AN UNKNOWN DATE, DUE TO UNKNOWN REASONS. X-RAYS RECEIVED AND REVIEWED, NOTING LOOSENING OF THE ACETABULAR COMPONENT, SUBSIDENCE OF THE FEMORAL COMPONENT, DISLOCATION OF THE FEMORAL HEAD, AND BONE FRACTURE OF THE ACETABULUM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2079559 BIOLOX DELTA OPTION CERAMIC HEAD 36MM PROSTHESIS, HIP LZO BIOMET UK LTD. 2958797 00887868271397

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other| R