BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 T1 PPS HO 11X142MM

    MDR report key: 9695832 · Received February 11, 2020

    Report

    Report Number
    0001825034-2020-00628
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 29, 2020
    Report Date
    March 30, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K101086
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE DEVICE WAS DETERMINED TO BE NOT REPORTABLE AS THERE WAS NO BREACH IN STERILITY. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE DEVICE WAS DETERMINED TO BE NOT REPORTABLE AS THERE WAS NO BREACH IN STERILITY. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: TPRLC 133 FP TYPE1 PPS SO 4.0, CAT#: 51-100040, LOT# 6118728. TPRLC XR MP T1 PPS 17X119MM, CAT#: 51-145170, LOT#: 3856409. TPRLC 133 FP TYPE1 PPS SO 5.0, CAT#: 51-100050, LOT#: 2870602. TPRLC 133 T1 PPS SO 14X148MM, CAT#: 51-103140, LOT#: 2772460. TPRLC 133 MP TYPE1 PPS HO 15.0, CAT#: 51-107150, LOT#: 3769795. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2020-00626, 0001825034-2020-00627, 0001825034-2020-00629, 0001825034-2020-00630, 0001825034-2020-00631.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEBRIS WAS FOUND IN STERILE PACKAGING WHILE INVESTIGATING STOCK. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158465 TPRLC 133 T1 PPS HO 11X142MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. NI 2775655

    Patients

    Seq Age Sex Outcome Treatment
    1