BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE (127 DEG) SIZE 2.5

    MDR report key: 2253322 · Received August 3, 2011

    Report

    Report Number
    9616680-2011-00511
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    April 14, 2011
    Report Date
    July 19, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K994366
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASSOCIATED DEVICE: CAT # 6364-2-328, LOT CODE G1713036 V40 FEM HEAD ORTHONIX 28+8. SUMMARY OF EVAL: THE ROOT CAUSE OF THE REPORTED EVENT WAS THAT THE WRONG COMBINATION OF DEVICES WERE PICKED PRE-OPERATIVELY AND THE SURGEON DID NOT CHECK THE DEVICES BEFORE IMPLANTATION. A REVIEW OF THE PACKAGING LABELS FOR THE (B)(4) ACCOLADE STEM SHOWS THAT THE WORDING "ACCOLADE TMZF" IS CLEARLY STATED ON ALL OF THE LABELS. A REVIEW OF THE PACKAGING LABELS FOR THE (B)(4) METAL HEAD SHOWS THAT THE WORDING "FOR USE W/(B)(4) STEMS ONLY" IS CLEARLY STATED ON THE MAIN PRODUCT LABEL. A REVIEW OF STRYKERS RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED, PACKED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER REPORTED EVENTS FOR THE REPORTED LOTS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE SALES REP THAT AN ACCOLADE STEM WAS IMPLANTED WITH A V40 FEMORAL HEAD. THE SALES REP AND CUSTOMER BOTH BELIEVE THAT THIS IS OFF-LABEL USAGE AS A STAINLESS STEEL HEAD WAS USED WITH A TMZF STEM. THE SALES REP FURTHER REPORTED THAT THE CUSTOMER BELIEVES THAT THE INSTRUCTION MANUALS FOR THE REPORTED PRODUCTS ARE NOT EXPLICITLY CLEAR ON WHAT OTHER PRODUCTS THEY ARE COMPATIBLE WITH. NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED. THE SALES REP REPORTED THAT THE THEATRE NURSE PICKED THE INCORRECT IMPLANT PRIOR TO SURGERY AND THIS MISTAKE WAS NOT IDENTIFIED BY THE SURGEON DURING SURGERY. THE SALES REP ADDED THAT THE SCRUB NURSE SHOWED THE IMPLANT TO THE SURGEON PRIOR TO IMPLANTING IT BUT THE SURGEON DID NOT REALIZE THAT THE IMPLANT WAS (B)(4). SALES REP FURTHER REPORTED THAT THE SURGEON HAS CONCERNS THAT THE PACKAGING IS NOT CLEARLY LABELED. THE SALES REP WAS NOT PRESENT DURING THE PROCEDURE AND WAS NOT CONSULTED REGARDING THE CHOICE OF DEVICES USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE (127 DEG) SIZE 2.5 IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 35952502

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other