BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11/13 S-ROM 44MM M SPEC+9

    MDR report key: 2930252 · Received January 25, 2013

    Report

    Report Number
    1818910-2013-11546
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    December 7, 2012
    Report Date
    January 9, 2013
    Manufacturer
    DEPUY INTL., LTD. ¿ REG. # 8010379
    Product Code
    LPH
    PMA / PMN Number
    PK060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE STERILIZATION CERTIFICATIONS AND DEVICE HISTORY RECORDS FOR THE PROVIDED PRODUCT/LOT COMBINATIONS DID NOT REVEAL ANY RELATED DEVIATIONS OR ANOMALIES. PER THE STERILIZATION CERTIFICATES, VALIDATED PARAMETERS WERE MET. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED INFECTION. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THE PATIENT WAS REVISED TO ADDRESS METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35643 11/13 S-ROM 44MM M SPEC+9 HEAD LPH DEPUY INTL., LTD. ¿ REG. # 8010379 2377338

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention