BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 TYPE1 PPS SO 13.0

    MDR report key: 7338753 · Received March 14, 2018

    Report

    Report Number
    0001825034-2018-01846
    Event Type
    Injury
    Date Received
    March 14, 2018
    Date of Event
    November 19, 2013
    Report Date
    May 16, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK101086
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: 12-115120, CER BIOLOXD MOD HD 36MM -3 NK, 725740; 010000665, G7 PPS LTD ACET SHELL 56F, 2981561; 010000858, G7 NEUTRAL E1 LINER 36MM F, 3078828. CUSTOMER HAS INDICATED THAT THE PRODUCT 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 REPORTS: 0001825034 - 2018 - 01847; 0001825034 - 2018 - 01848; 0001825034 - 2018 - 01849.

    Additional Manufacturer Narrative · 1

    THE FOLLOW UP REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION RECEIVED. THE COMPLAINT WAS CONFIRMED BASED ON THE SURGICAL OP NOTES THAT WERE PROVIDED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO INFECTION OF THE RIGHT HIP TWO MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT (I&D) PROCEDURE APPROXIMATELY SIX (6) WEEKS POST-IMPLANTATION DUE TO A DRAINING SURGICAL WOUND AND WOUND INFECTION. THEN, APPROXIMATELY A MONTH LATER, PATIENT UNDERWENT A 1ST STAGE REVISION WITH REMOVAL OF THEIR IMPLANTS DUE TO CHRONIC INFECTION OF THE RIGHT HIP. A LOOSE STEM WAS FOUND DURING THE REVISION. FOLLOWING RIGHT HIP STAGE I PROCEDURE, PATIENT UNDERWENT 2ND I&D FOUR (4) DAYS LATER. SUBSEQUENTLY, AN ADDITIONAL STAGED PROCEDURE WAS PERFORMED APPROXIMATELY FOUR (4) MONTHS LATER DUE TO A FAILED STAGE 1 PROCEDURE WITH RECURRENT INFECTION. PATIENT WAS REVISED TO A SPACER. LASTLY, PATIENT UNDERWENT A STAGE 2 RE-IMPLANTATION PROCEDURE THREE (3) MONTHS LATER. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182888 TPRLC 133 TYPE1 PPS SO 13.0 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 2835744

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R