BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPRLC 133 MP TYPE1 PPS HO 15.0

    MDR report key: 11971660 · Received June 9, 2021

    Report

    Report Number
    0001825034-2021-01763
    Event Type
    Injury
    Date Received
    June 9, 2021
    Date of Event
    April 30, 2021
    Report Date
    September 2, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    PMA / PMN Number
    K110400
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: ORIF RIGHT FEMUR W/ BONE GRAFT D/T PERIPROSTHETIC FRACTURE. FRACTURE OF LESSER TROCHANTER GOING DOWN 11 CM BELOW THE CALCAR. HIP WAS FIBROTIC AND IT TOOK TIME TO MOBILIZE THE FRACTURE FRAGMENTS FOR REDUCTION. STEM WAS FOUND LOOSE, BUT THE HEAD WAS REDUCED IN ACETABULUM. SHELL WAS WELL FIXED AND REMOVED WITHOUT BONE LOSS, BONE QUALITY NOTED TO BE GOOD. 3 DALL-MILES CABLES USED TO SECURE PROXIMAL FEMUR FRACTURE AS WELL AS COMPOSITE GRAFT PACKED ALONG FRACTURE SITE. NO COMPLICATIONS NOTED DURING REVISION PROCEDURE. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. 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

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: G7 58G ACETABULAR SHELL, CAT #: 010000666, LOT: 6925293, G VIVACIT-E POLY SIZE 40, CAT #: 30104007, LOT: 64986208, BIOLOX FEMORAL HEAD SIZE 40, CAT #: 650-1058, LOT: 3030921, TPR SLEEVE 0MM, CAT #: 650-1068, LOT: 3043548. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE WAS DISCARDED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT HIP ARTHROPLASTY APPROXIMATELY 2 MONTHS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 2.5 WEEKS LATER DUE TO A PERIPROSTHETIC FRACTURE AND THE STEM WAS FOUND LOOSE. 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
    867099 TPRLC 133 MP TYPE1 PPS HO 15.0 PROSTHESIS, HIP KWZ ZIMMER BIOMET, INC. N/A 6663545

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE