BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX OPTION TAPER SLEEVE 0MM

    MDR report key: 18873113 · Received March 11, 2024

    Report

    Report Number
    3002806535-2024-00083
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    February 12, 2024
    Report Date
    September 18, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271489
    PMA / PMN Number
    K192683
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IT IS LIKELY THE ROOT CAUSE IS NOT RELATED TO THE ITEMS REPORTED ON THIS COMPLAINT AS WE HAVE RECEIVED THE FOLLOWING INFORMATION: REVISION PROCEDURE TO CREATE A SHORTER CONSTRUCT FOR THE PATIENT. THERE WAS NOTHING WRONG WITH THE IMPLANT. 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 BIOLOXD OPTION HD 28MM, ITEM# 650-1055, LOT# 3094909. VIVACIT-E DM BEARING 28X44MM, ITEM# 110031012, LOT# 64912289. OSS FINN MOD PROX FMRL RT 7CM, ITEM# 150457, LOT# 667980. OSS 7CM DIAHPYSEAL SEGMENT, ITEM# 150466, LOT# 183630. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535 - 2024 - 00082. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H11. THE FOLLOWING SECTIONS WERE CORRECTED: H6. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IT IS LIKELY THE ROOT CAUSE IS NOT RELATED TO THE ITEMS REPORTED ON THIS COMPLAINT AS WE HAVE RECEIVED THE FOLLOWING INFORMATION THAT THE PATIENT WAS SKELETALLY IMMATURE AND DID NOT GROW AS FAST AS EXPECTED WHICH LED TO NEEDING TO SHORTEN THE CONSTRUCT TO MATCH THE OTHER LEG. 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.

    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 REVISION PROCEDURE OF THE RIGHT HIP TO CREATE A SHORTER CONSTRUCT DUE TO PATIENT'S ANATOMY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE OF THE RIGHT HIP TO CREATE A SHORTER CONSTRUCT DUE TO PATIENT'S ANATOMY. THE PATIENT WAS SKELETALLY IMMATURE AND DID NOT GROW AS FAST AS EXPECTED WHICH LED TO NEEDING TO SHORTEN THE CONSTRUCT TO MATCH THE OTHER LEG. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195297 BIOLOX OPTION TAPER SLEEVE 0MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO BIOMET UK LTD. N/A 3128066 00887868271489

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention| H SEE H10 NARRATIVE.