BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 MP TYPE1 PPS SO 12.0

    MDR report key: 8815560 · Received July 23, 2019

    Report

    Report Number
    0001825034-2019-03146
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    August 13, 2016
    Report Date
    October 9, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K110400
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 NOTES WERE REVIEWED AND IDENTIFIED PATIENT EXPERIENCED A DEEP INFECTION WITH A DURATION OF 77 DAYS. 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: 14-103656, UNIV 2-HOLE SHL 56MM LNR SZ 24, 619240; EP-105994, EPOLY 36MM RLC LNR MROM SZ24, 882430; 650-0660, DELTA CERAMIC FEM HD 36/-3MM, 2015080065. 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 - 2019 - 03143 SHELL; 0001825034 - 2019 - 03145 LINER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DEEP INFECTION WITH A DURATION OF 77 DAYS. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613005 TPRLC 133 MP TYPE1 PPS SO 12.0 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 3455265

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention