BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14

    MDR report key: 21421586 · Received February 20, 2025

    Report

    Report Number
    0009613350-2025-00079
    Event Type
    Injury
    Date Received
    February 20, 2025
    Date of Event
    January 28, 2025
    Report Date
    April 10, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024430365
    PMA / PMN Number
    K192416
    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: ITEM # 010000935, G7 HI-WALL E1 LINER 36MM E, LOT # 6744975, ITEM # 30.00.49-080, STEM MS-30 8 POLISHED, LOT # 3030382, ITEM # 01.00358.010, DISTAL CENTRALIZER 8/10 MS-30, LOT # 3038070, ITEM # 00801102020, ALLEN MEDULLARY CEMENT PLUGS 1-20 MM DIAMETER FLANGE/10 MM DIAMETER, CORE STORE IN COOL DRY PLACE, LOT # 64573394, ITEM # 010000703, G7 BONEMASTER LTD ACET SHL 52E, LOT # 6744975. 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

    (B)(4): THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED FOR EVALUATION. HOWEVER, TWO PICTURES WERE RECEIVED. IN ONE PICTURE, THE SHELL CAN BE SEEN (LINKED COMPLAINT (B)(4)), AND IN THE OTHER PICTURE, THE REVISED LINER (LINKED COMPLAINT (B)(4)) AND CERAMIC HEAD ARE VISIBLE. GIVEN THE BIOLOGICAL TISSUE ON THE PRODUCTS, IT CAN BE ASSUMED THAT THE PICTURES WERE TAKEN RIGHT AFTER THE REVISION SURGERY. THE CERAMIC HEAD IS COVERED IN BLOOD AND THEREFORE NO FURTHER ASSESSMENT CAN BE MADE. 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. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED THE INFORMATION RECEIVED THROUGH CORRESPONDENCE INDICATE THAT THE CUP POSITIONING WAS POOR. HOWEVER, 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). 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 PATIENT UNDERWENT HIP REVISION APPROXIMATELY 4 YEARS AND 3 MONTHS POST IMPLANTATION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    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 UNDERWENT A PRIMARY HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED FOUR (4) YEARS AND THREE (3) MONTHS POST IMPLANTATION DUE REOCCURRING DISLOCATIONS. THE CUP POSITIONING WAS POOR. LINER AND CUP WERE EXPLANTED. 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
    1028424 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14 PROSTHESIS, HIP LZO ZIMMER GMBH 3020310 00889024430365

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Hospitalization| R SEE H11 NARRATIVE.