BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 T1 PPS HO 18X156MM

    MDR report key: 8368383 · Received February 25, 2019

    Report

    Report Number
    0001825034-2019-00815
    Event Type
    Injury
    Date Received
    February 25, 2019
    Date of Event
    December 14, 2016
    Report Date
    March 1, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K101086
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THERE IS NO FAILURE ALLEGED AGAINST THE DEVICE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    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: S031140, SELEX/MAGNUM MOD HD 40MM -3, 967280; 16-116058, RNGLC+ LTD HOLE SHELL SZ58, 109120; EP-107825, E-POLY 40MM MAXROM LNR SZ25, 3521. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-00814. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED APPROX 3 YEARS POST IMPLANTATION DUE TO PAIN, ALTR AND PSEUDOTUMOR. DURING THE PROCEDURE LARGE PSEUDOTUMOR WAS REMOVED, NEGATIVE TESTS FOR INFECTION, DEBRIDEMENT OF NECROTIC TISSUE AND NOTED CORROSION ON BALL AND TAPER OF THE TRUNNION. LINER, TAPER ADAPTER AND HEAD WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159598 TPRLC 133 T1 PPS HO 18X156MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 3096152

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R