BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTRAL NECK USE WITH 12/14 TAPER STEMS ONLY 28

    MDR report key: 10395478 · Received August 12, 2020

    Report

    Report Number
    0001822565-2020-02882
    Event Type
    Injury
    Date Received
    August 12, 2020
    Date of Event
    March 15, 2010
    Report Date
    December 2, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K123019
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. MEDICAL RECORDS IDENTIFIED THE FOLLOWING : THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. THE PATIENT WAS REVISED DUE TO FAILED PAINFUL RIGHT TOTAL HIP ARTHROPLASTY, DURING WHEN ZIMMER BIOMET COMPONENTS WERE IMPLANTED. THE PATIENT WAS REVISED AGAIN DUE TO FAILED HIP ARTHROPLASTY. THERE WAS DISLOCATION OF THE PROSTHETIC JOINT. THE PATIENT HAD UNDERWENT 3 HIP SURGERIES WITH SUBSEQUENT INSTABILITY AND MULTIPLE DISLOCATIONS PRIOR TO THE PROCEDURE. REACTIVE SOFT TISSUE CHANGES PRESUMABLY FROM THIRD BODY WEAR. SOFT TISSUE REACTIVE CHANGES INVOLVING ESSENTIALLY DISSOLVING THE ENTIRE TROCHANTER OF THE RIGHT HIP AND ASSOCIATED SOFT TISSUE MUSCLES. THE STEM SHOWED AREAS OF EROSION PROXIMALLY. THE STEM AND CUP WERE WELL FIXED. LINER AND HEAD WERE REPLACED WITH NEW ZIMMER BIOMET PRODUCTS. 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.

    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: 437228065 METASULA INSERT SIZE 28MM X 65MM 1330661. 7354-02-207 SCHAFT NH M/KRAGEN 12/14 7 R 1192728. 4360-00-065 HEMIS POR SHELL W/SEALED 1367353. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT LOCATION IS UNKNOWN. 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 REPORTS: 0001822565 - 2020 - 02880.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY TEN YEARS POST IMPLANTATION ON DUE TO PAIN AND IMPLANT FAILURE. THE PATIENT WAS REVISED AGAIN ON TWENTY YEARS LATER DUE TO DISLOCATION, RECURRENT INSTABILITY AND MECHANICAL LOOSENING OF JOINT DUE TO POLY WEAR. DURING THE PROCEDURE, REACTIVE SOFT TISSUE CHANGES PRESUMABLY FROM THIRD BODY WEAR, WAS NOTED, OSTEOLYSIS OF THE GREATER TROCHANTER WAS NOTED. THE HEAD AND LINER WERE REMOVED AND REPLACED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863250 NEUTRAL NECK USE WITH 12/14 TAPER STEMS ONLY 28 PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 1340034

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10