BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLICA A STEM 12 MM

    MDR report key: 4242805 · Received November 11, 2014

    Report

    Report Number
    1818910-2014-31538
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK934334
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. UDI: (B)(4).

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED FEMORAL HEAD AND STEM FINDS EVIDENCE TO SUGGEST THE FEMORAL HEAD WAS NOT TAPER LOCKED. THE TAPERS WERE EVALUATED USING GOLDBERG METHODOLOGY, AND FOUND LITTLE TO NO EVIDENCE OF CORROSION OF THE HEAD AND MODERATE CORROSION OF THE STEM TAPER. EVIDENCE IS CONSISTENT WITH MILD TO MODERATE TAPER CORROSION. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.(B)(4)

    Description of Event or Problem · 1

    A REVISION WAS PERFORMED ON (B)(6) IN 2014 DUE TO ARMD. THE INITIAL THA SURGERY WAS PERFORMED IN 2004, AND THE HEAD WAS REVISED IN 2013 AT ANOTHER HOSPITAL DUE TO RECURRENT DISLOCATION. HOWEVER, THE PATIENT WAS ADMITTED TO THE HOSPITAL ON SUSPICION OF INFECTION. ALTHOUGH THE SURGEON FOUND DISASSOCIATION BETWEEN THE HEAD AND THE STEM, IT WAS UNABLE TO IDENTIFY ANY PATHOGEN ASSOCIATED WITH INFECTIONS. THERE WAS ALSO NO SIGN OF LEUKOCYTOSIS DESPITE AN INCREASE IN THE CRP. THUS, THE SURGEON EVENTUALLY CONCLUDED THAT THE PATIENT HAD BEEN SUFFERING FROM ARMD AND PERFORMED THE COMPLETE REMOVAL OF THE IMPLANTS. THE SURGEON BELIEVES THAT THE PATIENT'S JOINT WAS ALREADY LOOSE FROM LAST YEAR DUE TO LOSS OF SOFT TISSUES SUCH AS GLUTEAL MUSCLE BECAUSE OF AMRD. IMPLANTS INFORMATION: REPLICA 12MM, HEAD 28MM+6MM (CHANGED LAST YEAR). DURALOC 1200 52MM, LINER 52MM. DURING THE SURGERY, NECROSIS (WHITENING) THAT MIGHT BE ASCRIBED TO METAL DEBRIS WAS FOUND AROUND THE SOFT TISSUES (SCAR TISSUES) AND THE FEMUR PROXIMAL AREA. THE MINIMUS GLUTEUS MUSCLE WAS FOUND LOST AND MEDIUS GLUTEUS MUSCLE WAS ALSO FOUND LARGELY LOST. THE SYNOVIAL FLUID WAS WHITE. THE SURGEON REQUESTED SEM ANALYSIS OF THE HEAD NECK JUNCTION. THERE WAS A SURGICAL DELAY THAT TOOK 2 HOURS FOR THE REMOVAL. THE PATIENT IS NOW UNDER OBSERVATION FOR A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725162 REPLICA A STEM 12 MM HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS, INC. A71FT1

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention