BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 T1 PPS SO 10X140MM

    MDR report key: 14251000 · Received April 29, 2022

    Report

    Report Number
    0001825034-2022-00997
    Event Type
    Injury
    Date Received
    April 29, 2022
    Date of Event
    October 6, 2017
    Report Date
    May 25, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K101086
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: (B)(6). 163661- 28MM DIA COCR MOD HD -3MM NK-UNKNOWN, 110010464- E1 RINGLOC BIPOLAR 28X42MM-UNKNOWN. NAKAMURA, T., YAMAKAWA, T., HORI, J., GOTO, H., NAKAGAWA, A., TAKATSU, T., OSAMURA, N., SAITO, A., HAGIO, K., MOURI, K. (2021) CONJOINED TENDON PRESERVING POSTERIOR APPROACH IN HEMIARTHROPLASTY FOR FEMORAL NECK FRACTURES: A PROSPECTIVE MULTICENTER CLINICAL STUDY OF 322 PATIENTS. JOURNAL OF ORTHOPAEDIC SURGERY 29(3) 1¿8. HTTPS://DOI.ORG/10.1177/23094990211063963. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G3; H2; H3; H6 H6 COMPONENT CODE: MECHANICAL (G04) - STEM NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS; LOT IDENTIFICATION WAS NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING AN INITIAL LEFT HIP HEMIARTHROPLASTY, THE FEMUR FRACTURED WHEN INSERTING THE STEM. THE FRACTURE WAS STABILIZED WITH CERCLAGE WIRING. NO FURTHER COMPLICATIONS WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117761 TPRLC 133 T1 PPS SO 10X140MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Female Other