BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA HD 12/14 32X+3.5

    MDR report key: 21313619 · Received February 5, 2025

    Report

    Report Number
    0009613350-2025-00047
    Event Type
    Injury
    Date Received
    February 5, 2025
    Date of Event
    December 26, 2024
    Report Date
    March 7, 2025
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024430334
    PMA / PMN Number
    K192416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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; A PRODUCT EVALUATION COULD NOT BE PERFORMED. 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 FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. IT WAS REPORTED THAT AN INCORRECT HEAD SIZE WAS OPENED AND IMPLANTED. A REVISION SURGERY WAS PERFORMED ON THE SAME DAY, A FEW HOURS LATER WHERE THE SURGEON EXCHANGED THE INCORRECT HEAD (00-8775-032-03 - BIOLOX DELTA HD 12/14 32X+3.5) FOR THE CORRECT HEAD (00-8775-036-03 - BIOLOX DELTA HD 12/14 36X+3.5). REVIEW OF IFU: THE IFU DESCRIBES THAT THE TAPER SURFACE OF BOTH STEM AND FEMORAL HEAD MUST BE DRY AND FREE OF ANY FOREIGN MATTER (E.G., TISSUE PARTS, BONE OR CEMENT PARTICLES) BEFORE THEIR FINAL SETTING. IN ADDITION, DO NOT USE ANY COMPONENT IF DAMAGE IS FOUND OR CAUSED DURING SETUP OR INSERTION. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO OFF-LABEL - WRONG COMBINATION OF PRODUCT. THE SURGEON SELECTED A WRONG COMBINATION 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: ITEM # 110010244, G7 OSSEOTI 3 HOLE SHELL 52MM E, LOT # 66880788; ITEM # 00-6250-065-30, TRILOGY BONE SCR 6.5X30, LOT # 66970763; ITEM # 30103605, G7 VIT E NEUTRAL LNR 36MM E, LOT # 66736255; ITEM # 574101060, AVENIR CMPL HA STD NC SIZE 6, LOT # 3200744; ITEM # 00-8775-036-03, BIOLOX DELTA HD 12/14 36X+3.5, LOT # 3197480. 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 DUE TO WRONG SIZE FEMORAL HEAD IMPLANTED. 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
    54047 BIOLOX DELTA HD 12/14 32X+3.5 PROSTHESIS, HIP LZO ZIMMER GMBH 3137127 00889024430334

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Hospitalization| R SEE H11 NARRATIVE.