BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC COMPLETE PRIMARY STEM

    MDR report key: 19262785 · Received May 7, 2024

    Report

    Report Number
    0001825034-2024-01155
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    April 17, 2024
    Report Date
    July 17, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304521421
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CAT# 010000865 LOT# 6687401 G7 NEUTRAL E1 LINER 40MM G. CAT# 010001035 LOT# 6758487 COCR FEM HD 40MM TYPE 1 STD. CAT# 010000706 LOT# 6943834 G7 BONEMASTER LTD ACET SHL 58G. G2: FOREIGN ¿ AUSTRALIA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULDN¿T NOT BE PERFORMED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: A LEFT TOTAL HIP ARTHROPLASTY WITH CEMENT FIXATION OF THE ACETABULAR CUP. NO FRACTURE. NO RADIOLUCENCY. POSITION OF THE LEFT TOTAL HIP ARTHROPLASTY APPEARS TO BE APPROPRIATE. NO SIGNS OF LOOSENING. THE COMPLAINT CANNOT BE CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT 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 THAT THE PATIENT WAS UNDERWENT A LEFT HIP REVISION APPROXIMATELY TWO YEARS POST-IMPLANTATION DUE TO COMPLAINT OF AN INTERNALLY ROTATED LEG AND THE STEM BEING TOO ANTEVERTED. THE STEM, HEAD, AND LINER WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381221 TAPERLOC COMPLETE PRIMARY STEM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 3954940 00880304521421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11 NARRATIVE