BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM US ACETABULAR COMPONENT 54/48 N

    MDR report key: 2492435 · Received March 9, 2012

    Report

    Report Number
    9613350-2012-00300
    Event Type
    Other
    Date Received
    March 9, 2012
    Report Date
    February 20, 2012
    Manufacturer
    ZIMMER, INC
    Product Code
    KWA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    F/U RECEIVED ON AUGUST 30, 2012. THE PATIENT HAS HAD HIS REVISION SURGERY BUT THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. SHOULD THE PRODUCT BE RETURNED AND ADDITIONAL INFORMATION BECOME AVAILABLE, WE WILL SUBMIT AN AMENDED MEDICAL DEVICE REPORT. ZIMMER WILL CLOSE THIS CASE ONCE AGAIN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON JULY 6, 2015. THE DEVICES WERE RETURNED AND THE RESULT OF THE VISUAL EXAMINATION HAS BEEN MADE AVAILABLE. DEFORMATION PRESENT ON CIRCUMFERENTIAL FIN NEAR RIM. A OF THE DUROM ACETABULAR COMPONENT. WRITING AND SMALL OUTER EDGE DEFORMATION PRESENT ON RIM OF DUROM ACETABULAR CUP. SLIGHT SCRATCHING ON ARTICULATING SURFACE OF METASUL LDH FEMORAL HEAD. THIRD BODY PARTICLES PRESENT ON THE OUTER RIM OF THE METASUL LDH FEMORAL HEAD. SMALL DEFORMATION PRESENT ON THE OUTER EDGE OF THE FACE OF THE METASUL LDH FEMORAL HEAD. THE RESULT OF THE EXAMINATION DID NOT CHANGE THE RESULTS OF THE PREVIOUS ASSESSMENT IN WHICH ZIMMER IMPLEMENTED A NOTIFICATION IN JULY 2008 AS REFERENCED. THE DISTRIBUTION OF THIS PRODUCT WAS CEASED IN THE MEANWHILE. THEREFORE, ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED.

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND NO ISSUES IDENTIFIED. SUCH A COMPLEX PHYSIOLOGICAL REACTION LIKE A PSEUDOTUMOR IS A KNOWN RISK FOR THIS KIND OF METAL-ON-METAL IMPLANT AS STATED IN ZIMMER'S IFU (D011500213). 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 THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN 07/2008. 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. THE DISTRIBUTION OF THIS PRODUCT WAS CEASED MEANWHILE DUE TO BUSINESS REASONS. ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT RECEIVED AN ACETABULAR CUP AND THAT A CYST OF FLUID HAS FORMED AND PUTTING PRESSURE ON THE IMPLANT.

    Description of Event or Problem · 1

    IT HAS NOW BEEN REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012 DUE TO PRESSURE ON THE IMPLANT CAUSED BY "CYST OF FLUID."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM US ACETABULAR COMPONENT 54/48 N DUROM ACETABULAR COMPONENT AND METASUL KWA ZIMMER, INC 2359598

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR