BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOL SYS 8/12.0 SML ST

    MDR report key: 4232279 · Received November 6, 2014

    Report

    Report Number
    1818910-2014-31295
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    February 28, 2011
    Report Date
    March 28, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK060581
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    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.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.(B)(4).

    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

    PPD AND MEDICAL RECORDS RECEIVED. THIS COMPLAINT ISNOW LEGAL. PPD ALLEGES INFECTION. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDRREPORTABILITY, THE REVISION NOTE FROM (B)(6) 2011 INDICATED INFECTION AND ALLIMPLANTS WERE REMOVED AND PROSTALAC WAS IMPLANTED. DATE OF REIMPLANTION ISUNKNOWN AT THIS TIME.PPD GAVE ANOTHER REVISION DATE OF (B)(6) 2011, BUT NO IMPLANTS WERE REMOVEDAND PATIENT HAD AN I&D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714070 SOL SYS 8/12.0 SML ST HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS, INC. E5XG21

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention