BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*SLEEVE PRX ZTT, 18D-LRG

    MDR report key: 3319044 · Received August 30, 2013

    Report

    Report Number
    1818910-2013-25750
    Event Type
    Injury
    Date Received
    August 30, 2013
    Date of Event
    May 8, 2013
    Report Date
    August 15, 2013
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS ¿ REG.
    Product Code
    LPH
    PMA / PMN Number
    PK934412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. 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. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES 2141329, AK1F61000, 2135770, AND 2148610. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODES 2129079, 2021906 AND 1913280 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A 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

    LITIGATION ALLEGES PAIN, DISCOMFORT, INFLAMMATION AND ELEVATED METAL ION LEVELS. UPDATE: (B)(6) 2013 - PFS AND MEDICAL RECORDS RECEIVED. PART/LOT WAS PROVIDED. OPERATIVE NOTES FOR THE LEFT HIP INDICATED INFECTION. ALL PRODUCTS HAVE BEEN REPORTED FOR THE LEFT HIP. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429701 S-ROM*SLEEVE PRX ZTT, 18D-LRG SLEEVE LPH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS ¿ REG. 2148610

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other