BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAN TAP CORT SCR SS 4.5X60MM

    MDR report key: 23905948 · Received December 29, 2025

    Report

    Report Number
    3002806535-2025-00672
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    October 16, 2018
    Report Date
    December 29, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00880304002296. D10: AVAN CMNTD SHELL SS 50MM; ITEM NUMBER # P0463050; LOT NUMBER# RA01207895 AVAN REINF RING SS 48/58MM; ITEM NUMBER# P0464858; LOT NUMBER# 0000950718 AVAN TAP CORT SCR SS 4.5X48MM; ITEM NUMBER# P0606048; LOT NUMBER# 0000975228 AVAN TAP CORT SCR SS 4.5X56MM; ITEM NUMBER# P0606056; LOT NUMBER# 0000891244 AVAN TAP CORT SCR SS 4.5X52MM; ITEM NUMBER# P0606052; LOT NUMBER# 0001071684 AVAN TAP CORT SCR SS 4.5X58MM; ITEM NUMBER# P0606058; LOT NUMBER# 0000910840 AVAN TAP CORT SCR SS 4.5X26MM; ITEM NUMBER# P0606026; LOT NUMBER# 0001082137 AVAN TAP CORT SCR SS 4.5X20MM; ITEM NUMBER# P0606020; LOT NUMBER# 0001064913 AVANTAGE INLAY S50 / 28; ITEM NUMBER# P0561050; LOT NUMBER# 0001197280 TAPERLOC STEM; ITEM NUMBER# 14-13200; LOT NUMBER# 604300 28MM DIA COCR MOD HD -3MM NK; ITEM NUMBER# 163661; LOT NUMBER# 249660 MEDACTA KERBOUL CROSS; ITEM NUMBER# UNKNOWN; LOT NUMBER# UNKNOWN HERMA ALLOGRAFT; ITEM NUMBER# UNKNOWN; LOT NUMBER# UNKNOWN HERAEUS MEDICAL BONE CEMENT; ITEM NUMBER# 66022683; LOT NUMBER# 85944588 G2: FOREIGN - EVENT OCCURRED IN CANADA. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K082446. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 1 YEAR, 3 MONTHS AND 2 DAYS POST IMPLANTATION DUE TO LOOSENING, PAIN, AND DIFFICULTIES WITH ADL¿S. DURING THE REVISION NOTED INFLAMMATION AND SCLEROTIC BONE. IT WAS ALSO NOTED THAT THE STEM HAS SOME DAMAGE TO THE TAPER BUT REMAINED IMPLANTED. THE ACETABULAR CONSTRUCT AND ALLOGRAFT, ZIMMER PLATE, SCREWS, CUP, BONE CEMENT AND HEAD WERE EXCHANGED WITHOUT COMPLICATIONS. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1893192 AVAN TAP CORT SCR SS 4.5X60MM HIP PROSTHESIS LZO BIOMET UK LTD. 0000911993

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11 NARRATIVE