BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL COCR HEAD 44/-8 'XS' 12/14

    MDR report key: 2071873 · Received April 19, 2011

    Report

    Report Number
    9613350-2011-00236
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    February 3, 2011
    Report Date
    March 25, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN THE U.S. THE MFR DID NOT RECEIVE EXPLANTED DEVICES OR X-RAYS. THE OP REPORT HAS BEEN REVIEWED. IT CONFIRMS A CHRONIC INCOMPETENCE OF THE GLUTEUS MEDIUS TENDON AND EXCESSIVE BONE VOLUME, WHICH LEAD TO ANTERIOR BONY IMPINGEMENT. AFTER THE RESECTION OF THE EXCESSIVE BONE, THE TENDENCY TO DISLOCATE WAS REMOVED. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. IT IS NOT SUSPECTED THAT PRODUCT FAILURE LEAD TO THE ALLEGED EVENT. SHOULD ADD'L INFO BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVAL AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER (B)(4) CONSIDERS THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT UNDERWENT REVISION SURGERY DUE TO RECURRENT DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURASUL COCR HEAD 44/-8 'XS' 12/14 DURASUL COCR HEAD LPH ZIMMER GMBH 60837504

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization