BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT

    MDR report key: 21161990 · Received January 15, 2025

    Report

    Report Number
    0001822565-2025-00139
    Event Type
    Injury
    Date Received
    January 15, 2025
    Report Date
    March 23, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    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

    (B)(4). D10: CAT# 00-6250-065-50 LOT# 64561604 TRILOGY BONE SCREW; CAT# 00700005620 LOT# 64564812 TRABECULAR METAL REVISION SHELL 56MM; CAT# 00662406540 LOT# 64645209 BONE SCREW SELF-TAPPING 40MM LENGTH 6.5 MM DIA; 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# 147420 ARCOS 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 OPTION HD40MM; CAT# 650-1067 LOT# 3031106 CER OPTION TYPE 1 TPR SLEVE+3. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY, AND IT WAS DETERMINED THAT THE FOLLOWING IMPLANTS ARE NOT COMPATIBLE: THE 00625006550 SCREW WITH THE TMARS CUP, AND THE AUGMENT, AND THE G7 LINER WITH THE TMARS CUP. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT CANNOT BE CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2. UPON AN INTERNAL DATA REVIEW, IT WAS DETERMINED THAT THIS DEVICE WAS REPORTED UNDER THE INCORRECT MANUFACTURER. THIS REPORT SHOULD BE CONSIDERED VOID, AND THE EVENT WILL BE REPORTED UNDER MFR (B)(4). 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

    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.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364047 TRABECULAR METAL ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT PROTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 63392067 00889024306844

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other