BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEAD ADAPTER L/+4; 12/14-18/20

    MDR report key: 2140377 · Received June 16, 2011

    Report

    Report Number
    1822565-2011-01405
    Event Type
    Injury
    Date Received
    June 16, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    C9613350-07/15/2008-001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER, (B)(4), WHICH MARKETS THE DEVICES IN THE UNITED STATES. THE MFR DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW 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 HAS LEAD TO THE ALLEGED EVENT. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THE REVISION SURGERY IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008. SHOULD ADDITIONAL 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. ZIMMER REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT IS PT'S DAUGHTER STATED THAT PT WAS HAVING CONSTANT PAIN, WENT TO SEE ANOTHER ORTHOPEDIC DOCTOR AND THAT DOCTOR ADVISED PT TO CONTACT ZIMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEAD ADAPTER L/+4; 12/14-18/20 DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2422000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other