BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 T1 PPS SO 12X144MM

    MDR report key: 9386072 · Received November 27, 2019

    Report

    Report Number
    0001825034-2019-05374
    Event Type
    Injury
    Date Received
    November 27, 2019
    Report Date
    December 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K101086
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG#: 110010267 G7 OSSEOTI MULTIHOLE 58MM G LOT#: 3899651, CATALOG#: 650-1064 CER OPTION TYPE 1 TPR SLEVE -6 LOT#: 2912211, CATALOG#: 010000937 G7 HI-WALL E1 LINER 36MM G LOT#: 3814614, CATALOG#: 650-1057 CER BIOLOXD OPTION HD 36MM LOT#: 2897734, CATALOG#: 010000998 G7 SCREW 6.5MM X 25MM LOT#: 6091325, CATALOG#: 010000998 G7 SCREW 6.5MM X 25MM LOT#: 3727750, CATALOG#: 010000997 G7 SCREW 6.5MM X 20MM LOT#: 6062820 CATALOG#: 010000994 G7 APICAL HOLE PLUG LOT#: 3676795, CATALOG#: 31-323230 3.2MMX30MM RNGLC+ ACET DRL BIT LOT#: 110590. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO LOCATION OF DEVICE IS UNKNOWN. 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: 0001825034-2019-03828, 0001825034-2019-03827, 0001825034-2019-03829, 0001825034-2019-03830.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT IS EXPERIENCING PAIN POST ¿IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179580 TPRLC 133 T1 PPS SO 12X144MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 6143215

    Patients

    Seq Age Sex Outcome Treatment
    1 Other