BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HGP II ACETABULAR BONE SCREW SELF-TAPPING 40 MM LENGTH 6.5 MM DIA.

    MDR report key: 19906435 · Received August 5, 2024

    Report

    Report Number
    0002648920-2024-00247
    Event Type
    Injury
    Date Received
    August 5, 2024
    Report Date
    January 15, 2025
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    UDI-DI
    00889024127685
    PMA / PMN Number
    K840643
    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. 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

    (B)(4). D10: CAT# 00625006550 LOT# 64561604 BONE SCREW SELF-TAPPING 6.5 MM DIA. 50 MM LENGTH. CAT# 00489405810 LOT# 63392067 TRABECULAR METALÂ ACETABULAR REVISION SYSTEM ACETABULAR AUGMENT. CAT# 00662406550 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 OPTIONHD40MM. CAT# 650-1067 LOT# 3031106 CER 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001822565-2024-02532.

    Description of Event or Problem · 0

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

    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
    1844833 HGP II ACETABULAR BONE SCREW SELF-TAPPING 40 MM LENGTH 6.5 MM DIA. PROTHESIS, HIP JDI ZIMMER MANUFACTURING B.V. N/A 64645209 00889024127685

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other