BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17405683 · Received July 27, 2023

    Report

    Report Number
    0009613350-2023-00421
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    July 18, 2023
    Report Date
    September 18, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    UDI-DI
    00889024430365
    PMA / PMN Number
    K192416
    Removal / Correction Number
    N/A
    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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED, BUT TWO PICTURES WERE PROVIDED AND ASSESSED. THE ARTICULATION SURFACE AND THE BEVEL OF THE BIOLOX HEAD SHOW SOME BLACK METAL SMEARS, BUT ARE OTHERWISE INCONSPICUOUS. THE TAPER SHOWS A REGULAR SEATING PATTERN CONSISTING OF CIRCUMFERENTIAL METAL SMEARS IN THE LOWER PART OF THE TAPER. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE PATIENT UNDERWENT A LEFT THA DUE TO OSTEOARTHRITIS. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO DISLOCATION. DURING THE REVISION PROCEDURE IMPINGEMENT AND SCAR TISSUE WERE ALSO NOTED. TWO X-RAYS FROM THE INITIAL SURGERY WERE PROVIDED AND REVIEWED, HOWEVER, THEY DO NOT ENHANCE THE INVESTIGATION OF REPORTED EVENT IN THIS COMPLAINT. WITH THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - MEDICAL DEVICES: G7 BONEMASTER LTD ACET SHL 56F; ITEM# 010000705; LOT# 6813056. BIOLOX DELTA CER LNR 36MM F; ITEM# 110003623; LOT# 6839566. 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.

    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 A PATIENT UNDERWENT LEFT HIP ARTHROPLASTY. APPROXIMATELY 2 YEARS LATER, A REVISION PROCEDURE WAS PERFORMED DUE TO DISLOCATION. DURING THE REVISION PROCEDURE IMPINGEMENT AND SCAR TISSUE WERE ALSO NOTED. THE CUP, HEAD, AND LINER WERE EXCHANGED WITHOUT ANY REPORTED COMPLICATIONS AND NO FURTHER INFORMATION IS KNOWN AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258209 BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3047826 00889024430365

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention| H SEE H10 NARRATIVE.