BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM US ACETABULAR COMPONENT 54/48 N

    MDR report key: 2583020 · Received May 15, 2012

    Report

    Report Number
    9613350-2012-00528
    Event Type
    Other
    Date Received
    May 15, 2012
    Date of Event
    April 26, 2012
    Report Date
    April 26, 2012
    Manufacturer
    ZIMMER GMBH
    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

    THE MFR DID NOT YET 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. 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 (B)(4) 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 AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS CASE WAS REOPENED 10/04/2012. THIS CASE WAS REOPENED TO RECTIFY THE DATE OF THE REVISION SURGERY. DEVICE STILL NOT RECEIVED. THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008 AS REFERENCED. CASE WILL BE CLOSED ONCE AGAIN. ZIMMER REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    FOLLOW UP REPORT RECEIVED ON 08/30/2012. REVISION SURGERY WAS PERFORMED BUT THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION. ONCE THE PRODUCT IS RETURNED AND ADDITIONAL INFORMATION BECOME AVAILABLE, AN UPDATED FOLLOW-UP REPORT WILL BE SUBMITTED. THIS CASE WILL BE CONSIDERED CLOSE ONCE AGAIN. ZIMMER REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 06/24/2015. THE DEVICES WERE RETURNED AND THE RESULT OF THE VISUAL EXAMINATION HAS BEEN MADE AVAILABLE. REVIEW OF EVENT DESCRIPTION: PRODUCT WAS IMPLANTED ON (B)(6) 2008 AND WAS REVISED ON (B)(6) 2012 DUE TO PAIN, LOOSENING, ELEVATED METAL IONS, FLUID COLLECTION. SURGICAL REPORT: IMPLANTATION NOTES SURGERY WAS ACCORDING TO STANDARD PROTOCOL. REVISION NOTES STATES THAT: THE DUROM CUP COULD BE REMOVED WITHOUT EFFORT/BONE LOSS. REVIEW OF SURGICAL REPORT DID NOT LEAD TO NEW INFORMATION REGARDING THE REPORTED EVENT. VISUAL EXAMINATION: DURING THE VISUAL EXAMINATION THE DUROM ACETABULAR PRESENTED PARTIAL BONY ON GROWTH IS PRESENT ON THE POROUS COATING, MATERIAL DEFORMATION ON THE POROUS COATING OF THE DUROM CUP AS WELL AS TO THE CIRCUMFERENTIAL FINS OF RIMM. MATERIAL DEFORMATION IS PRESENT ON THE FACE OF THE ARTICULATING HEAD AND HEAD ADAPTER. THIRD PARTY MATERIAL IS PRESENT AROUND THE END WHICH CONNECTS TO THE STEM. 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. ZIMMER REFERENCE NUMBER OF THIS CASE (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT RECEIVED AN ACETABULAR CUP AND THAT A REVISION SURGERY WAS SCHEDULED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT REVISION SURGERY ON (B)(6) 2012 DUE TO PREMATURE LOOSENING OF THE DUROM CUP. IT WAS ALSO REPORTED THAT THERE WAS "CONCERN FOR ELEVATED COBAL CHROME LEVELS."

    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 GMBH 2424618

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other