BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLOCLASSIC®, SL STEM, OFFSET, UNCEMENTED, 5, TAPER 12/14

    MDR report key: 20064539 · Received August 26, 2024

    Report

    Report Number
    0009613350-2024-00402
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    July 12, 2024
    Report Date
    August 26, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    UDI-DI
    00889024590373
    PMA / PMN Number
    K200112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM # 00877504002, BIOLOX DELTA HEAD 12/14 40X0, LOT # 3160761. ITEM # 30124006, G7 VIT E HIGH WALL LNR 40MM F, LOT # 66098678. ITEM # 010000665, G7 PPS LTD ACET SHELL 56F, LOT # 7440511. ITEM # 98000100129, PR PRM ST/G7 CP/VE LN/CER/INS, LOT # UNKNOWN. G2: REPORT SOURCE US. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF ALL RELEVANT DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND NO ADDITIONAL RELATED COMPLAINTS FOR THE REPORTED PART LOT COMBINATION. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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 PATIENT UNDERWENT HIP REVISION POST IMPLANTATION DUE TO THE STEM SUBSIDING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273562 ALLOCLASSIC®, SL STEM, OFFSET, UNCEMENTED, 5, TAPER 12/14 PROSTHESIS, HIP JDI ZIMMER GMBH N/A 3038531 00889024590373

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H