BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIG RPF HP FLEX SHIM SZ 2.5-5

    MDR report key: 1973492 · Received January 13, 2011

    Report

    Report Number
    1818910-2011-00221
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 14, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY (B)(4), REPORTS: DURING SURGERY, THE SHIM COULD NOT BE REMOVED FROM THE SPACER BLOCK BECAUSE FIXATION WAS TOO HARD. EXAMINATION OF THE RETURNED PRODUCTS WAS UNABLE TO CONFIRM THE REPORTED EVENT. RELATED DIMENSIONAL INSPECTION OF THE RETURNED PRODUCTS DID NOT IDENTIFY ANY DISCREPANCY THAT WOULD CONTRIBUTE TO THE REPORTED EVENT. A COMPLAINT DATABASE SEARCH DID NOT IDENTIFY A TREND FOR THIS PRODUCT CODE IN REGARDS TO THE REPORTED EVENT. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. BASED ON THE INVESTIGATION FINDINGS, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD 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

    DURING SURGERY, THE SHIM COULD NOT BE REMOVED FROM THE SPACER BLOCK BECAUSE FIXATION WAS TOO HARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIG RPF HP FLEX SHIM SZ 2.5-5 87 LXH LXH DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA