BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPT TYPE 1 TPR SLEVE 0MM

    MDR report key: 18474445 · Received January 9, 2024

    Report

    Report Number
    3002806535-2024-00009
    Event Type
    Injury
    Date Received
    January 9, 2024
    Report Date
    January 19, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271489
    PMA / PMN Number
    K200959
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H1, H2, H3, H6, H10. LIMITED INVESTIGATIONS DO NOT NEED TO HAVE THE RAW MATERIAL CERTIFICATE, STERILIZATION CERTIFICATE, COMPLAINT HISTORY, PRODUCT HOLD/FIELD ACTION PULLED AND REVIEWED. ALSO, A REVIEW OF THE RISK MANAGEMENT FILE HAS NOT BEEN COMPLETED AS THE PRODUCT IS CONSIDERED UNRELATED TO THE REPORTED EVENT. COMPLAINTS ARE MONITORED PER SOP263 COMPLAINT TRENDING PROCESS. DEVICES ARE USED FOR TREATMENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS WERE NOT PROVIDED. THE ROOT CAUSE OF THE REPORTED ISSUE IS UNRELATED TO THE ZIMMER BIOMET MEDICAL DEVICE. 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: CER OPT TYPE 1 TPR SLEVE 0MM; ITEM# 650-1066; LOT# 3048736 CER BIOLOXD OPTION HD 36MM; ITEM# 650-1057; LOT# 3103921 G7 OSSEOTI MULTIHOLE 56MM F; ITEM# 110010266; LOT# 65300747 TRILOGY BONE SCR 6.5X35; ITEM# 00-6250-065-35; LOT# J7258386 TRILOGY BONE SCR 6.5X25; ITEM# 00-6250-065-25; LOT# J7263672 3.2MMX30MM RNGLC+ ACET DRL BIT; ITEM# 31-323230; LOT# 495410 G7 APICAL HOLE PLUG; ITEM# 010000994; LOT# 7130450 G7 VIT E 10DEG LNR 36MM F; ITEM# 30113606; LOT# 65312681 3.2MMX40MM RNGLC+ ACET DRL BIT; ITEM# 31-323240; LOT# 457220 MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535 - 2024 - 00009 3002806535 - 2024 - 00010 INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. 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 THE PATIENT UNDERWENT A HIP ARTHROPLASTY SURGERY. SUBSEQUENTLY, THE PATIENT IS BEING REVISED DUE TO A FALL AND POOR BONE QUALITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553373 CER OPT TYPE 1 TPR SLEVE 0MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO BIOMET UK LTD. N/A 3048736 00887868271489

    Patients

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