BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CERAMIC OPTION HD 28MM

    MDR report key: 22435095 · Received July 8, 2025

    Report

    Report Number
    3002806535-2025-00254
    Event Type
    Injury
    Date Received
    July 8, 2025
    Date of Event
    June 10, 2025
    Report Date
    October 24, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271373
    PMA / PMN Number
    K200959
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11. 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. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - ASSOCIATED MEDICAL DEVICES: G7 DUAL MOBILITY LINER 38MM C; ITEM# 110024461; LOT# 806990. 28MM I.D. 38MM O.D. SIZE C BEARING; ITEM# 110031009; LOT# 65560533. CER OPTION TYPE 1 TPR SLEVE +6; ITEM# 650-1068; LOT# 3111626. TPRLC XR MP T1 PPS 13X111MM; ITEM# 51-145130; LOT# 6209866. G7 LOW PROFILE SCREW Ø6.5X15MM; ITEM# 10000996; LOT# 6263545. G7 LOW PROFILE SCREW Ø6.5X35MM; ITEM# 10001000; LOT# 6219960. G7 LOW PROFILE SCREW Ø6.5X35MM; ITEM# 10001000; LOT# 6245599. G7 OSSEOTI MULTIHOLE 48MM C; ITEM# 110010262; LOT# 6312347. G2 - FOREIGN: JAPAN. 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 IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE, FOLLOWED BY A REVISION SURGERY APPROXIMATELY FOUR YEARS LATER DUE TO A DISLOCATION. SUBSEQUENTLY, APPROXIMATELY TWO YEARS AND SIX MONTHS AFTER THE REVISION, THE PATIENT EXPERIENCED ANOTHER DISLOCATION THAT REQUIRED SURGICAL INTERVENTION. DURING THE CLOSED REDUCTION, THE BEARING AND HEAD DISASSOCIATED, NECESSITATING A SECOND REVISION SURGERY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373069 BIOLOX DELTA CERAMIC OPTION HD 28MM HIP PROSTHESIS LZO BIOMET UK LTD. 3123626 00887868271373

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H