BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRSVN ALLPOLY TIB LMRL S2 7MM

    MDR report key: 1040462 · Received May 8, 2008

    Report

    Report Number
    1818910-2008-01502
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 9, 2008
    Manufacturer
    DEPUY - RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC
    Product Code
    HRY
    PMA / PMN Number
    K010810
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PROD WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER REPORTS AGAINST THE MFG LOT. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE REPORTED PAIN. THE INITIAL REPORTING STATED VERY MINOR POLYETHYLENE WEAR WAS NOTED AT REVISION SURGERY. NO EVIDENCE WAS FOUND SUGGESTING PROD ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PROD AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED TO ADDRESS PAIN, POLYETHYLENE WEAR NOTED. DOR 4/9/2008 (LEFT SIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRSVN ALLPOLY TIB LMRL S2 7MM 87HRY HRY DEPUY - RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC NA Z21AJ4000

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention