BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLY LINER FOR DELTA HIP PROSTHESIS

    MDR report key: 3521347 · Received November 27, 2013

    Report

    Report Number
    3008021110-2013-00026
    Event Type
    Other
    Date Received
    November 27, 2013
    Date of Event
    November 6, 2013
    Report Date
    November 7, 2013
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    LPH
    PMA / PMN Number
    K112898
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BY THE EVENT INFO, IT SEEMS THAT THE DELTA POLY LINER WITH PRODUCT CODE 5886.51.158 HAD A DIMENSIONAL ANOMALY WHICH PREVENTED THE CORRECT SEATING OF THE DIA.32 MM TRIAL FEMORAL HEAD, SO THE SURGEON HAD TO USE A DIA.36 MM FEMORAL HEAD TO COMPLETE THE SURGERY. WE REQUESTED MORE INFO TO THE COMPLAINT SOURCE, BUT ONLY ON (B)(6) 2013 WE REC'D CONFIRMATION BY THE COMPLAINT SOURCE (THROUGH A PHONE CALL) THAT THERE'S NOTHING DEFECTIVE WITH THE LINER USED DURING THE SURGERY. WE KNOW THAT ALSO A DELTA POLY LINER NUMBER LARGE FOR DIA.36 MM FEMORAL HEAD (PRODUCT CODE 5886.51.260) WAS AVAILABLE IN OPERATING ROOM DURING THE SURGERY. IT'S LIKELY THAT THIS LINER WAS REALLY IMPLANTED TOGETHER WITH THE DIA.36 MM FEMORAL HEAD, AND THAT THE SURGEON FOR UNK REASON BELIEVED HE HAD IMPLANTED THE NUMBER MEDIUM FOR DIA.32 MM FEMORAL HEAD (PRODUCT CODE 5886.51.158). BEFORE BECOMING AWARE THAT THE LINER INVOLVED WAS NOT DEFECTIVE, WE HAD CHECKED THE WORK CYCLE RELATED TO THE LINER (BATCH 201310811-1300252) W/O DETECTING ANY DIMENSIONAL ANOMALY. (B)(4). MOREOVER, WE HAD DIMENSIONALLY CHECKED ANOTHER PIECE WITH THE SAME BATCH WHICH WAS ON THE MARKET, W/O DETECTING ANY ANOMALY ON IT. THE ABOVE CHECKS CONFIRM WHAT REPORTED BY THE COMPLAINT SOURCE ON (B)(6) 2013, I.E. THAT THE DELTA POLY LINER CLAIMED AS "DEFECTIVE" WAS COMPLIANT TO ALL SPECIFICATIONS. THE SIGNALING OF THE INTRA-OPERATIVE ISSUE WAS CAUSED BY CONFUSION OF THE OPERATOR (THE SURGEON BELIEVED HE HAD USED A DELTA POLY LINER NUMBER MEDIUM FOR DIA.32 MM FEMORAL HEAD, BUT HE HAD REALLY USED A LINER NUMBER LARGE FOR DIA.36 MM FEMORAL HEAD). (B)(4). AS THIS WAS A "WRONG" SIGNALING AND THE DELTA POLY LINER WAS COMPLIANT TO ALL SPECIFICATIONS, THE OCCURRENCE RATE OF SUCH A PROBLEM IS 0.

    Description of Event or Problem · 1

    INTRA-OPERATIVE ISSUE SIGNALED FROM (B)(6) AND REPORTED TO LIMACORPORATE ON (B)(6) 2013. IT WAS REPORTED THAT, DURING SURGERY, THE SURGEON OPENED THE PACKAGE OF A DELTA POLY LINER WITH PRODUCT CODE 5886.51.158 (# MEDIUM FOR DIA. 32 MM FEMORAL HEAD); THEN HE NOTICED THAT THE TRIAL DIA.32 MM FEMORAL HEAD WAS TOO SMALL FOR THE LINER, SO HE COMPLETED THE SURGERY BY IMPLANTING A DIA.36MM FEMORAL HEAD WHICH SEATED CORRECTLY INTO THE ABOVE DELTA POLY LINER. NO CONSEQUENCES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621277 POLY LINER FOR DELTA HIP PROSTHESIS LPH, MBL LPH LIMACORPORATE S.P.A. 5886.51.158 201310811-1300252

    Patients

    Seq Age Sex Outcome Treatment
    1