BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 16D-SML

    MDR report key: 3802271 · Received May 9, 2014

    Report

    Report Number
    1818910-2014-18431
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    DEPUY IRELAND REG. # 9616671
    Product Code
    LPH
    PMA / PMN Number
    PK934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICES FINDS NOTHING OUTWARD TO SUGGEST ABNORMAL WEAR. TRIBIOLGOCIAL MATTER IS OBSERVED ON BOTH MALE AND FEMALE TAPERS. IT CANNOT BE DETERMINED IF THE DAMAGE FOUND ON THE RIM OF THE INSERT IS FROM EXTRACTION. THE ACETABULAR CUP WAS NOT RETURNED FOR EXAMINATION. MATCHING DAMAGE IS NOT FOUND ON THE FEMORAL HEAD OR FEMORAL STEM. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT/LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. NO PATIENT DEMOGRAPHICS, INVESTIGATIONAL INPUTS, OR FURTHER EVENT INFORMATION WAS PROVIDED. THE INVESTIGATION CAN DRAW NO CONCLUSIONS 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.

    Description of Event or Problem · 1

    ON (B)(6) 2007, THE ORIGINAL THA SURGERY WAS DONE. ON (B)(6) 2007, THE PATIENT WAS REVISED DUE TO THE FREQUENT DISLOCATION. THE HEAD SIZE WAS EXCHANGED FROM 0 TO 3 DURING THIS SURGERY. ON 2013, IN THE MRI & CT, IT WAS SUSPECTED THAT PSEUDOTUMOR AROUND THE HIP JOINT WHEN PATIENT VISITED HOSPITAL FOR ROUTINE EXAMINATION. HENCE, ON (B)(6) 2014, THE PATIENT WAS REVISED AGAIN, THERE WAS OBSERVED THE NECROSED OF SOFT TISSUES AROUND THE HIP JOINT AND THE METALLOSIS ON THE BETWEEN OF THE NECK-HEAD AND THE STEM-SLEEVE. AS A RESULT, THE ALL NECROSED SOFT TISSUES WERE REMOVED AND EXCHANGED IMPLANT AS BELOW. LINER WAS EXCHANGED TO POLYETHYLENE, HEAD WAS EXCHANGED TO DELTA AND THE STEM WAS EXCHANGED AS NEW SAME STEM. ACCORDING TO SURGEON, IT WAS SUSPECTED THAT THE ROOT CAUSE IS RELATED TO ASSEMBLAGE OF 9/10 TAPER AND 36 MM HEAD. THERE WERE NO SURGICAL DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280915 S-ROM*SLEEVE PRX ZTT, 16D-SML HIP FEMORAL STEM/SLEEVE LPH DEPUY IRELAND REG. # 9616671 2415311

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention