BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL REVISION SHELL 56MM

    MDR report key: 19885612 · Received August 1, 2024

    Report

    Report Number
    0001822565-2024-02532
    Event Type
    Injury
    Date Received
    August 1, 2024
    Report Date
    March 23, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00889024310872
    PMA / PMN Number
    K001759
    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# 00489405810; LOT# 63392067; TRABECULAR METALÂ ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT. 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. 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.

    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 3005751028. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4;D4;G3;H2;H3;H4;H6;H10. 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.

    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.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379235 TRABECULAR METAL REVISION SHELL 56MM PROTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 64564812 00889024310872

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other