BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT

    MDR report key: 21048439 · Received December 31, 2024

    Report

    Report Number
    3005751028-2024-00006
    Event Type
    Injury
    Date Received
    December 31, 2024
    Report Date
    January 15, 2025
    Manufacturer
    ZIMMER TMT
    Product Code
    LPH
    UDI-DI
    00889024306844
    PMA / PMN Number
    K042871
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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;H2;H3;H6 THE FOLLOWING SECTIONS WERE CORRECTED: H11 UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 1822565 ZIMMER.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 00-6250-065-50 LOT# 64561604 TRILOGY BONE SCREW CAT# 00662406540 LOT# 64645209 BONE SCREW SELFTAPPING 40MM CAT# 00-6624-065-50 LOT#63704590 BONE SCR 6.5X50 SELF-TAP CAT# 11-300814 LOT# 774180 ARCOS 14X150MM SPL TPR DIST CAT# 11-300818 LOT# 147420ARCOS 18X150MM SPL TPR DIST CAT# 010000903 LOT# 3743858 G7 10 DEG E1 LINER 40MM F CAT# 11-301331 LOT# 138850 ARCOS CON SZ A HI 70MM CAT# 650-1058 LOT# 2993268 CER BIOLOXD OPTIONHD40MM CAT# 650-1067 LOT# 3031106CER OPTION TYPE 1 TPR SLEVE+3 CAT# 00700005620 LOT# 64564812 TRABECULAR METAL REVISION SHELL 56MM. PRODUCT REMAINS IMPLANTED WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED, AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 1822565 ZIMMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 4 YEARS POST IMPLANTATION OF A RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT IS EXPERIENCING PAIN AND A LOOSE CUP. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION ON AN UNKNOWN DATE. NO ADDITIONAL INFORMATION WAS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1782794 TRABECULAR METAL ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT PROTHESIS, HIP LPH ZIMMER TMT N/A 63392067 00889024306844

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other