BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ8 HI OFF

    MDR report key: 3202753 · Received July 2, 2013

    Report

    Report Number
    1818910-2013-20414
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    February 15, 2012
    Report Date
    June 5, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES 2218848, BG4DP4000, YK1JJ1000, AND A1XEX1000 . A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 2378481 SINCE THEIR RELEASE FOR DISTRIBUTION; HOWEVER, A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR 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 REVISED FOR PAIN, PSEUDO TUMOR, AND ELEVATED COBALT/CHROME LEVEL. UPDATE: (B)(6) 2012. LITIGATION PAPERS RECEIVED. UPDATE: (B)(6) 2012 - MEDICAL RECORDS AND PATIENT FACT SHEET RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION. RECORDS ARE AVAILABLE ON THE L\DRIVE IF NEEDED FOR FURTHER REVIEW. UPDATE: (B)(6) 2013- UPON MEDICAL RECORD REVIEW BY A MEDICAL PROFESSIONAL, IT WAS DISCOVERED THAT THE PATIENT SUFFERED FROM SIGNIFICANT FLUID BUILD-UP, METALLOSIS, AND BLACK STAINING OF THE TRUNION- IDENTIFIED AS CORROSION. THE CUP AND STEM HAVE NOW BEEN ADDED AND ALL PRODUCTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300997 SUMMIT POR TAPER SZ8 HI OFF FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US A1XEX1000

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention