BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 FP TYPE1 PPS SO 4.0

    MDR report key: 13952846 · Received March 30, 2022

    Report

    Report Number
    0001825034-2022-00751
    Event Type
    Injury
    Date Received
    March 30, 2022
    Date of Event
    February 5, 2018
    Report Date
    April 21, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K120030
    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). 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. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: 163651-22.2MM DIA COCR MOD HD STD NK-UNKNOWN. 110010716-E1 RINGLOC BIPOLAR 22X40MM-UNKNOWN. 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 PATIENT EXPERIENCED INTRAOP TROCHANTERIC FRACTURES. NO TREATMENT OR INTERVENTION WAS PROVIDED, AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. 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

    IT WAS REPORTED DURING AN INITIAL LEFT HIP HEMIARTHROPLASTY, THE IMPACTOR PUSHED THE TROCHANTER WHEN INSERTING THE STEM FRACTURING THE TROCHANTER. NO ADDITIONAL INTERVENTION OR TREATMENT WAS PROVIDED. 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
    843089 TPRLC 133 FP TYPE1 PPS SO 4.0 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Other SEE H10 NARRATIVE.