BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA POLY LINER PROTRUDED, I.D. 36MM, #LARGE

    MDR report key: 4275380 · Received November 25, 2014

    Report

    Report Number
    3008021110-2014-00019
    Event Type
    Malfunction
    Date Received
    November 25, 2014
    Date of Event
    October 24, 2014
    Report Date
    October 24, 2014
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K112898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE CHECKED THE WORK CYCLES OF THE 2 DELTA POLY LINERS + TI6AL4V RINGS INVOLVED, WITHOUT FINDING ANY PRE-EXISTING ANOMALY ON THE 57 PIECES MANUFACTURED WITH THE LOT # 201400441 (34 PIECES SURELY USED) AND 39 PIECES MANUFACTURED WITH THE LOT # 201315701 (21 PIECES SURELY USED). WE DID NOT RECEIVE ANY OTHER SIGNALING RELATED TO THESE LOT #. WE ALSO RECEIVED THE PROTRUDED POLY LINERS INVOLVED IN THIS INTRA-OPERATIVE ISSUE, WHICH UNDERWENT A FURTHER DIMENSIONAL CHECK. FOR BOTH LINERS, WHICH WERE UNAVOIDABLY DEFORMED DURING THEIR USE, WE NOTICED A SLIGHT CHANGE OF SOME DIMENSIONS (EXTERNAL CONICITY ANGLES AND CONSEQUENTLY EXTERNAL DIAMETERS), IF COMPARED WITH THE DIMENSIONAL CHECK PERFORMED BEFORE PLACING THE DEVICES ON THE MARKET. THE SAME HAPPENED FOR THE EXTERNAL CONICITY ANGLE OF THE 2 TI6AL4V RINGS; AS THESE RINGS ARE VERY THIN, THEY ARE EASILY DEFORMABLE WHEN USED. HOWEVER, THE ROUGHNESS OF THE RETURNED RINGS IS COMPLIANT TO SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. WE THEN PERFORMED TWO SEPARATE FUNCTIONAL CHECKS WITH THE RETURNED LINERS AND A SAMPLE OF DELTA CUP WITH THE SAME DIAMETER OF THE ONE INVOLVED IN THE ISSUE , FOLLOWING THE INDICATIONS OF THE SURGICAL TECHNIQUE. AFTER INSERTING THE POLY LINERS INTO THE CUP WITH THE FINGERS AND CHECKING FOR THEIR CORRECT LODGING, WE NOTICED THAT THE LINERS WERE ALREADY STABLE INSIDE THE CUP, JUST AFTER APPLYING A SLIGHT PRESSURE WITH THE FINGER, WITHOUT THE NEED OF PERFORMING THE AXIAL IMPACTION WITH THE PROPER INSTRUMENT (INDICATION REPORTED IN THE SURGICAL TECHNIQUE). THIS TEST ALLOWED US TO CONFIRM THAT THE DELTA POLY LINERS COULD PERFORM WELL DURING THE SURGERY, AFTER FOLLOWING THE INDICATIONS REPORTED IN THE SURGICAL TECHNIQUE. A POSSIBLE CAUSE OF THE ISSUE IS THE PRESENCE OF SOFT TISSUE / PARTICLES BETWEEN LINER AND CUP, WHICH PREVENTED THE CORRECT COUPLING BETWEEN THE COMPONENTS DURING SURGERY. WITH REGARD TO THIS, THE DELTA SURGICAL TECHNIQUE SPECIFIES: "BEFORE INSERTING THE DEFINITIVE ARTICULAR LINER, CLEAN THE INTERIOR RIM OF THE CUP/SPACER CAREFULLY AND CHECK THAT SOFT TISSUES WILL NOT INTERFERE WITH DEFINITIVE LINER INSERTION". ANOTHER POSSIBLE CAUSE IS THE SUBOPTIMAL POSITIONING OF THE LINER INSIDE THE SPACER DURING SURGERY; IN FACT, THE CONICITY ANGLE OF THE PROTRUDED LIP OF THE LINER IS DIFFERENT WITH REGARDS TO THE "COUPLING" CONICITY ANGLE OF THE LINER, THIS MAY MISLEAD SURGEONS WHEN INSERTING THE POLY LINER AND MAY LEAD TO A MISALIGNMENT BETWEEN LINER AND CUP OR SPACER; THE FACT THAT WE DID NOT RECEIVE SIMILAR COMPLAINTS FOR NEUTRAL POLY LINERS IS A CONFIRMATION OF THIS. WE ARE AWARE OF 8 TOTAL CASES OF INTRA-OPERATIVE INSTABILITY INVOLVING A PROTRUDED DELTA POLY LINER MARKETED IN THE US (MODEL # 5886.50.XXX-5886.51.XXX) AND A DELTA CUP OR DELTA SPACER. A TOTAL OF 22786 DELTA POLY LINERS PROTRUDED HAVE BEEN MARKETED WORLDWIDE SINCE 2007 SO, ACCORDING THE ABOVE PMS DATA, THE TOTAL OCCURRENCE RATE OF SUCH ISSUE IS 0.035%. ALL THE ABOVE CASES EXCEPT ONE ARE ABOUT AN INTRA-OPERATIVE INSTABILITY BETWEEN A DELTA PROTRUDED POLY LINER (MARKETED IN THE US) AND DELTA CUPS OR DELTA SPACERS WHICH ARE NOT MARKETED IN THE US. BEFORE BECOMING AWARE OF THIS ISSUE, LIMACORPORATE PLANNED THE MODIFICATION OF THE TI6AL4V RING OF THE LINER TO SATISFY MANUFACTURING NEEDS. THE NEW RINGS ARE SANDBLASTED (THE PREVIOUS ONES WERE SHOT-PEENED); INTERNAL TESTS HIGHLIGHTED ALSO THAT LINERS WITH SANDBLASTED RINGS HAVE AN HIGHER ROTATIONAL STABILITY INSIDE THE CUP THAN LINERS WITH SHOT-PEENED RINGS. LIMACORPORATE IS ALSO EVALUATING THE OPPORTUNITY TO ISSUE A COMMUNICATION TO THE SALES FORCE (AND AN IMPROVEMENT OF THE DELTA SURGICAL TECHNIQUE) WITH ADDITIONAL SUGGESTIONS ON HOW TO REACH A STABLE INTRA-OP COUPLING BETWEEN DELTA POLY LINERS PROTRUDED AND CUPS OR SPACERS.

    Description of Event or Problem · 1

    DURING A HIP SURGERY DATED (B)(6) 2014, TWO DELTA POLY LINERS PROTRUDED WITH DIFFERENT LOT # DID NOT FIND A STABLE COUPLING INSIDE A DELTA ONE TT CUP (CUP NOT MARKETED IN THE US). THE POLY LINERS HAVE A TI6AL4V RING ON ITS OUTER SHELL; THE RING IS USED TO GIVE STABILITY TO THE CONICAL COUPLING BETWEEN LINER AND CUP. THE SURGEON CONCLUDED THE SURGERY BY USING A NEUTRAL POLY LINER WHICH REMAINED WELL FIXED INSIDE THE CUP. SURGICAL TIME PROLONGED BY 10 MINUTES. THE INTRA-OPERATIVE ISSUE OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763718 DELTA POLY LINER PROTRUDED, I.D. 36MM, #LARGE LPH, MBL LPH LIMACORPORATE S.P.A. 5886.51.260 201315701

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization