BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 16B-LRG

    MDR report key: 3200065 · Received July 1, 2013

    Report

    Report Number
    1818910-2013-20244
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    May 28, 2013
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ¿ REG. # 1219655
    Product Code
    LPH
    PMA / PMN Number
    PK934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    MEDWATCH 1818910-2013-20244 WAS CREATED IN ERROR. PLEASE DISREGARD.

    Additional Manufacturer Narrative · 1

    MEDWATCH 1818910-2013-20244 WAS CREATED IN ERROR. PLEASE DISREGARD.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS DISLOCATION. UPDATE: (B)(6) 2011 - LITIGATION PAPERS RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. UPDATE: (B)(6) 2013- UPON MEDICAL RECORD REVIEW BY A MEDICAL PROFESSIONAL, IT WAS DISCOVERED THAT THE CUP DISLOCATED AND THE STEM AND SLEEVE FAILED. POLY WEAR WAS ALSO NOTED. THE CUP, STEM, AND SLEEVE HAVE NOW BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297637 S-ROM*SLEEVE PRX ZTT, 16B-LRG FEMORAL SLEEVE LPH DEPUY-RAYNHAM, A DIV. OF DEPUY ¿ REG. # 1219655 1809257

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention