BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR NECK G 12/14 NECK TAPER USE WITH +0 HEADS ONLY LZO

    MDR report key: 8861921 · Received August 5, 2019

    Report

    Report Number
    0001822565-2019-03337
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    April 10, 2018
    Report Date
    January 10, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K063251
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A5, B4, B5, B7, G4, G7, H2, H3, H6, H10. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING : THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. ZIMMER BIOMET PRODUCTS WERE IMPLANTED WITHOUT ANY COMPLICATIONS. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2018 DUE TO PAIN, LOOSENING, PERIPROSTHETIC FRACTURE, ELEVATED METAL ION LEVELS, COMORBIDITIES, HEMATOMA, NECROSIS, IN VIVO CORROSION, HETEROTOPIC OSSIFICATION, DIFFICULTY AMBULATING, DECREASE IN ADLS, PSEUDOTUMOR, FAILURE TO OSTEOINTEGRATE, OSTEOLYSIS, DISLOCATION, ADVERSE LOCAL TISSUE REACTION, AND INSTABILITY. DURING REVISION IT WAS NOTED THAT THE FEMORAL HEAD WAS REMOVED WITHOUT DIFFICULTY FROM THE TRUNNION. THE FEMALE TAPER ASPECT OF THE HEAD REVEALED NO GROSS METALLOSIS. THE TRUNNION AT THIS TIME REVEALED MILD TAPER CORROSION WITH NO GROSS DAMAGE TO THE TRUNNION AREA. THE NECK OF THE FEMORAL STEM WAS COLD-WELDED TO THE STEM, AND THEREFORE NOT REMOVED. THE RESIDUAL STEM WAS DETERMINED TO BE STABLE BOTH AXIALLY AND ROTATIONALLY. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00771301000, MODULAR FEMORAL STEM PRESS-FIT, 61813586, 00801803602, FEMORAL HEAD 12/14 TAPER, 61841705, 00630505036, LINER STANDARD 3.5 MM OFFSET 36 MM I.D, (B)(6), 00620005422, SHELL POROUS WITH CLUSTER HOLES 54 MM O.D., (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2019-03314. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REVISION SURGERY, THE NECK OF THE FEMORAL STEM WAS COLD-WELDED TO THE STEM, AND THEREFORE NOT REMOVED. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656161 MODULAR NECK G 12/14 NECK TAPER USE WITH +0 HEADS ONLY LZO PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 61680670

    Patients

    Seq Age Sex Outcome Treatment
    1