BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 MP TYPE1 PPS HO 16.0

    MDR report key: 8659468 · Received May 31, 2019

    Report

    Report Number
    0001825034-2019-02374
    Event Type
    Injury
    Date Received
    May 31, 2019
    Date of Event
    April 18, 2019
    Report Date
    August 23, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI - (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. REVIEW OF THE MEDICAL RECORDS IDENTIFIED THAT THE PATIENT HAD RECEIVED TREATMENT FOR A UTI, POST IMPLANTATION. 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. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    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: ITEM# 10000858, ACETABULAR LINER, LOT# 6463319; ITEM# 010000665, ACETABULAR CUP, LOT# 6435946; ITEM# 650-1057, CER BIOLOXD OPTION HD 36MM, LOT# 2950529; ITEM# 650-1066, CER OPT TYPE 1 TPR SLEVE 0MM, LO # 2954554. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, (AS THE PRODUCTS REMAIN IMPLANTED). 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: 0001822565-2019-02267, 0001822565-2019-02371.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD INITIAL RIGHT TOTAL HIP PERFORMED. SUBSEQUENTLY, LESS THAN 30 DAYS POST OP THE PATIENT DEVELOPED AN URINARY TRACT INFECTION (UTI) AND WAS TREATED WITH ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453671 TPRLC 133 MP TYPE1 PPS HO 16.0 HIP PROSTHESIS KWA ZIMMER BIOMET, INC. N/A 6450916

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O