BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC TPRLC 133 T1 PPS HO 15X150MM

    MDR report key: 19047132 · Received April 4, 2024

    Report

    Report Number
    0001825034-2024-00958
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    May 3, 2023
    Report Date
    June 11, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304489776
    PMA / PMN Number
    K101086
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT# 16-104156 LOT# 645350 RNGLC+ LTD HOLE FIN SHL SZ56, CAT# 11-363665 LOT# 328680 36MM COCR MOD HD +9MM, CAT# 103533 LOT# 900690 TI LOW PROFILE SCREW 6.5X30MM, CAT# XL-105894 LOT# 544650 ARCOMXL RLC 10DEG 36MM SZ24. PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: 0001825034-2024-00959.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4;G3;H2;H3;H4;H6. H6: COMPONENT CODE: MECHANICAL (G04) - STEM. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AN INITIAL RIGHT TOTAL HIP ARTHROSCOPY WAS PERFORMED. APPROXIMATELY FOUR YEARS LATER, AN ASPIRATION OCCURRED DUE TO PAIN. THE RESULTS SHOWED INFLAMMATION. THE PATIENT WAS THEN REVISED DUE TO PAIN, ELEVATED METAL IONS, AND METALLOSIS. BLACK MATERIAL WAS NOTED ON THE INSIDE OF THE HEAD AND TRUNNION, AND THE TRUNNION WAS NO LONGER SMOOTH. ALL PRODUCTS WERE EXPLANTED AND REPLACED WITH COMPETITOR PRODUCTS. THIS COMPLAINT WAS CONFIRMED BASED ON THE PROVIDED MEDICAL RECORDS; HOWEVER, 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 5 YEARS POST IMPLANTATION OF A RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO, FLUID ACCUMULATION IN THE JOINT, AND ELEVATED METAL ION LEVELS. DURING SURGERY, METALLOSIS WAS CONFIRMED AND DETERMINED TO BE RELATED TO THE TRUNNION HEAD INTERFACE. THE HEAD WAS REMOVED, AND THE TRUNNION WAS NOTED TO BE A VERY SHORT TRUNNION WITH A +9MM HEAD HIGH OFFSET STEM, WHICH THE SURGEON BELIEVED PREDISPOSED THE PATIENT TO METALLOSIS. METALLOSIS WAS NOTED AROUND THE TRUNNION WITH BLACK MATERIAL ON THE INSIDE OF THE HEAD AND THE TRUNNION ITSELF. ALL COMPONENTS WERE EXCHANGED WITH COMPETITOR PRODUCT WITHOUT COMPLICATIONS. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED THAT APPROXIMATELY 5 MONTHS PRIOR TO THE PATIENT¿S HIP REVISION, 20ML WAS ASPIRATED FROM THE RIGHT GREATER TROCHANTERIC AREA DUE TO PAIN. NUMBING MEDICATION WAS INJECTED WITHOUT STEROIDS. THE PAIN WAS MINIMALLY RESOLVED WITH INJECTION; HOWEVER, THE PAIN RETURNED. THE PATIENT REMAINED ON CHRONIC PREDNISONE THERAPY. A SECOND INJECTION WAS PLANNED PRIOR TO THE REVISION. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2340729 TAPERLOC TPRLC 133 T1 PPS HO 15X150MM PROTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 6320163 00880304489776

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R