BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM

    MDR report key: 2090124 · Received May 5, 2011

    Report

    Report Number
    2249697-2011-00656
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    September 3, 2010
    Report Date
    April 9, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 690-00-22E, LOT # MJDJTD, DESCRIPTION: TRIDENT 0 DEG CONSTRAINED INSERT 22E. THIS IS THE SAME PT/EVENT AS MFR # 9616680-2011-00280.

    Description of Event or Problem · 1

    IT WAS REPORTED: PT ORIGINALLY WENT IN FOR A THA ON (B)(6) 2010. A 54M TRITANIUM SHELL USED, WITH SCREWS AND A 32 'E 0 DEGREE X3 LINER. EXETER 44 #2 STEM WAS ALSO IMPLANTED (ALONG WITH 32MM LFIT V40 HEAD AND 12MM BONE PLUG). THREE TO FOUR WEEKS POST-OP, PT DISLOCATED HIP (PT WAS POTENTIALLY PUSHING RECOVERY TOO HARD, BY REACHING DOWN TO TOUCH TOES AND IN THE PROCESS TORE HER GLUTEAL MUSCLES). THIS WAS FOLLOWED BY 1-2 MORE DISLOCATIONS, BEFORE A REVISION ON (B)(6) 2010 TO PUT IN A CONSTRAINED LINER. SHELL REMAINED IN SITU FROM THE REVISION, WITH ORIGINAL LINER REMOVED AND CONSTRAINED LINER INSERTED. GLUTEAL MUSCLES WERE ALSO RE-ATTACHED USING MITEK ANCHORS. SIX WEEK POST-REVISION X-RAY WAS ALL GOOD, HOWEVER PT FELT CLICKING IN HIP AND GRABBING PAIN IN (B)(6) 2010. RECEIVED AN X-RAY ON (B)(6) 2011, WHERE ANOTHER REVISION WAS RECOMMENDED. RE-REVISION WAS PERFORMED ON (B)(6) 2011, WHERE THE TRIATANIUM SHELL FROM THE ORIGINAL OPERATION ((B)(6) 2010) AND CONSTRAINED LINER (FROM (B)(6) 2010 REVISION) WAS REMOVED AND REPLACED WITH A TRIATANIUM 56MM 'E' SHELL (ALONG WITH 3X SCREWS) AND TRIDENT 0 DEGREE CONSTRAINED LINER 'E' (AND ASSOCIATED 22MM HEAD). THE ORIGINAL EXETER STEM REMAINED IN SITU".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA MHLEWV

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other| R