BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 28MM

    MDR report key: 17780840 · Received September 20, 2023

    Report

    Report Number
    3002806535-2023-00312
    Event Type
    Injury
    Date Received
    September 20, 2023
    Date of Event
    August 27, 2023
    Report Date
    October 9, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    K200959
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PICTURE IDENTIFIED A MARK ON THE SURFACE OF THE CERAMIC HEAD. NOTHING CAN BE GAINED FROM THE PHOTOGRAPH OF THE HEAD WITH REGARDS TO CAUSE OF THE REPORTED DISLOCATION. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. THE DEVICE IS USED FOR TREATMENT. MEDICAL RECORDS WERE NOT PROVIDED. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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: CER OPT TYPE 1 TPR SLEVE 0MM; REF#650-1066; LOT#3050938. VIVACIT-E DM BEARING 28X44MM; REF#110031012; LOT#65781071. G7 DUAL MOBILITY LINER 44MM F; REF#110024464; LOT#949240. ARCOS CON SZ A STD 50MM; REF#11-301300; LOT#65788746. BONE SCR 6.5X30 SELF-TAP; REF#00625006530; LOT#J7421000. ARCOS 14X150MM SPL TPR DIST; REF#11-300814; LOT#65938420. G7 OSSEOTI 4 HOLE SHELL 56MM F; REF#110010246; LOT#65616938. 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 APPROXIMATELY TWO MONTHS POST-IMPLANTATION OF LEFT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO A 28MM HEAD DISASSOCIATION FROM A 44MM BEARING THAT WAS IMPLANTED. THE PATIENT HAD ABDUCTOR INSUFFICIENCY AND DISLOCATED. IT IS BELIEVED THAT THE HEAD DISASSOCIATED FROM THE DUAL WHEN THE EVENT HAPPENED, OR WHEN AN ATTEMPT WAS MADE TO RELOCATE IT. IT WAS NOTED THAT SURGICAL TECHNIQUE WAS UTILIZED, AND THE DUAL WAS ASSEMBLED PROPERLY DURING THE ORIGINAL SURGERY. THE PATIENT WAS CONVERTED TO A CONSTRAINED PRODUCT. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88535 CER BIOLOXD OPTION HD 28MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO BIOMET UK LTD. N/A 3114832

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10 NARRATIVE