BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 TYPE1 BM SO 11.0

    MDR report key: 7869992 · Received September 12, 2018

    Report

    Report Number
    0001825034-2018-08836
    Event Type
    Injury
    Date Received
    September 12, 2018
    Date of Event
    August 28, 2018
    Report Date
    June 20, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PNA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES : DELTA CER FEM HD 32/0MM T1, PN 650-1162, LN 201700745. REPORT SOURCE: (B)(6). 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. THIS PRODUCT IS NOT CLEARED FOR DISTRIBUTION IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS A SIMILAR DEVICE IS CLEARED FOR DISTRIBUTION UNDER K101086.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO EXCESSIVE PAIN AND STEM SUBSIDENCE APPROXIMATELY 1-MONTH POST OP. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711323 TPRLC 133 TYPE1 BM SO 11.0 PROSTHESIS HIP KWA ZIMMER BIOMET, INC. N/A 6037281

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R