BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACETABULAR COMPONENT 56/50 P

    MDR report key: 2032566 · Received March 15, 2011

    Report

    Report Number
    9613350-2011-00147
    Event Type
    Injury
    Date Received
    March 15, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 3, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    C9613350-07/15/2008-001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 (B)(4). THE MANUFACTURER DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS. THE SURGICAL REPORT OF THE INITIAL SURGERY DOES NOT PROVIDE ANY INDICATION FOR THE ROOT CAUSE OF THE ALLEGED EVENT. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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 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 RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2007. IT IS ALSO REPORTED THAT POST OP, PT EXPERIENCED PAIN AND WAS REVISED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABULAR COMPONENT 56/50 P DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER GMBH 2353156

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization