BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +1.5

    MDR report key: 3103095 · Received May 9, 2013

    Report

    Report Number
    1818910-2013-16849
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). UDI #: (B)(4). (B)(4) USED TO CAPTURE THE SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND POTENTIAL ALLERGIC REACTION.

    Description of Event or Problem · 1

    PINNACLE CLAIM SUBMISSION FORM, STICKER SHEETS AND MEDICAL RECORDS RECEIVED VIA CD SHIPMENT LAST 08 APR 2019. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAIN. OPERATIVE FINDINGS INCLUDE MILD METAL-ON-METAL SOFT TISSUE REACTION WITHOUT EXTENSIVE NECROSIS OR CORROSION, MILD YELLOWING OF SURFACE MEMBRANE BUT NO DEEP EXTENSIVE MUSCLE NECROSIS, CLEAR FLUID WITH NO EVIDENCE OF HAZY DISCOLORATION AND YELLOWING OF THE LINING OVER THE TROCHANTER, ABDUCTORS AND PSEUDOMEMBRANE INSIDE THE HIP. THE TRUNNION, TAPER AND HEAD DID NOT HAVE ANY CORROSION OR DAMAGE AND THE STEM WAS SOLIDLY FIXED WITH NO EVIDENCE OF LOOSENING OR OSTEOLYSIS. NO CORROSION AT THE RIM OF THE LINER AND NO SCORING, DAMAGE OR CORROSION ON THE BACK OF THE LINER. THE TWO SCREWS, LINER AND FEMORAL HEAD WERE REVISED, RETAINING THE CUP AND THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203816 ARTICULEZE M HEAD 36MM +1.5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY ORTHOPAEDICS INC US 1928130

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention