BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPRLC 133 FP TYPE1 PPS SO 4.0

    MDR report key: 9738380 · Received February 21, 2020

    Report

    Report Number
    0001825034-2020-00816
    Event Type
    Malfunction
    Date Received
    February 21, 2020
    Date of Event
    January 30, 2020
    Report Date
    April 3, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K120030
    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 T1 PPS HO 17X154MM 4MM T1, CAT# 51-104170 LOT# 6052090, TPRLC 133 T1 PPS HO 9X137MM MM T1, CAT# 51-104090 LOT# 3856292, TPRLC 133 FP TYPE1 PPS SO 4.0, CAT# 51-100040 LOT#2949049 , TPRLC 133 T1 PPS HO 13X146MM 6MM T1, CAT# 51-104130 LOT# 3639315, TPRLC XR T1 PPS 17X154MM MM T1, CAT# 51-105170 LOT# 3863579. 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 -00813, 0001825034 -2020 -00814, 0001825034 -2020 -00815, 0001825034 -2020 -00817, 0001825034 -2020 -00818.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STERILE PACKAGES WERE DAMAGED. NO HOSPITALS WERE INVOLVED. 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
    200534 TPRLC 133 FP TYPE1 PPS SO 4.0 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. NI 2949057

    Patients

    Seq Age Sex Outcome Treatment
    1