BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUROM US ACETABULAR COMPONENT 56/50 P

    MDR report key: 1811199 · Received August 10, 2010

    Report

    Report Number
    9613350-2010-00380
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    March 31, 2010
    Report Date
    July 26, 2010
    Manufacturer
    ZIMMER GMBH
    Product Code
    KXA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT HAS NOW UNDERGONE REVISION SURGERY. ONCE THE DEVICE IS RETURNED TO THE MANUFACTURER FOR INVESTIGATION AND THE RESULT BECOMES AVAILABLE, AN UPDATED REPORTED WILL BE SUBMITTED. ZIMMER REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    INFORMATION WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICE IN THE U.S. THE MANUFACTURER DID NOT RECEIVED EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR EXPLANTED DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. WHILE A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS EVENT IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008 AS REFERENCED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION 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. REFERENCE NUMBER OF THIS FILE: (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. IT WAS ALSO REPORTED THAT PATIENT EXPERIENCED PAIN AND LOSS OF MOVEMENT. REVISION HAS NOT TAKEN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174907 DUROM US ACETABULAR COMPONENT 56/50 P DUROM ACETABULAR COMPONENT KXA ZIMMER GMBH NA 2417423

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other