BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUROM ACETABULAR COMPONENT

    MDR report key: 3770610 · Received January 23, 2014

    Report

    Report Number
    9613350-2014-03456
    Event Type
    Other
    Date Received
    January 23, 2014
    Date of Event
    January 6, 2014
    Report Date
    January 6, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, AS THE PATIENT HAS NOT BEEN REVISED AND IS CURRENTLY BEING MONITORED. THE CAUSE FOR THIS COMPLAINT HAS NOT BEEN REPORTED, BUT SINCE THE DATE OF THE IMPLANTATION HAS NOT BEEN PROVIDED, THIS CASE WILL BE TREATED AS A COMPLAINT THAT MIGHT BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTIVE ACTION IN JULY 2008 AS NOTIFICATION Z-2415/2426-2008. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RCVD ON (B)(4) 2017. THE DEVICE WAS RETURNED FOR INVESTIGATION AND THE INVESTIGATION RESULTS ARE AVAILABLE. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. EVENT SUMMARY: PATIENT HAD DUROM CUP, IMPLANTED ON THE RIGHT HIP ON (B)(4) 2007 AND REVISED ON (B)(4) 2012 DUE TO PAIN AND LOOSENING. THIS IS A BILATERAL PATIENT. REVIEW OF RECEIVED DATA - INTRAOPERATIVE RECORD OF IMPLANTATION REPORT THE REFERENCE AND LOT NUMBER OF THE IMPLANTED COMPONENTS AS WELL AS THE "PRE-CARE" ACTIONS. IMPLANTATION OP REPORT LEFT DATED ON (B)(4) 2007 REPORTS THE IMPLANTATION OF A DUROM CUP SIZE 54 WITH LDH HEAD SIZE 48 DUE TO DEGENERATIVE ARTHROSIS. THE REPORT STATES THAT A SIZE 54 ACETABULAR COMPONENT WAS IMPACTED INTO PLACE IN THE APPROPRIATE ORIENTATION. STABILITY WAS CHECKED WITH A PUSH PULL TEST AND THE CUP WAS FOUND TO BE STABLE. REVISION REPORT DATED (B)(4) 2012 REPORTS THE REVISION OF THE DUROM CUP DUE TO LOOSENING AND DISPLACEMENT OF THE ACETABULAR COMPONENT. IT IS ALSO REPORTED THAT A TEST CONFIRMED A MARKED ALLERGY OR HYPERSENSITIVITY TO NICKEL. THE CUP WAS GROSSLY LOOSE. THE NEW COMPONENTS WERE IMPLANTED. DEVICES ANALYSIS - THE RETURNED PARTS SHOWS DAMAGE FROM THE REVISION SURGERY SUCH AS NICKS AND SCRATCHES AND ARE PARTIALLY COVERED WITH SOME ORGANIC DEPOSITS. THE POROUS COATING OF THE DUROM ACETABULAR COMPONENT EXHIBITED LACK OF BONE ON GROWTH AND SOME SLIGHTLY POLISHED AREAS. SOME TRACES OF BIOLOGICAL MATERIAL ARE ALSO VISIBLE. THE SURFACE OF LDH HEAD IS SCRATCHED. THE HEAD TAPER IS INCONSPICUOUS. ON THE INNER SURFACE OF THE HEAD ADAPTER SURFACE CHANGES DUE TO FRETTING CORROSION AS WELL AS ONE MARK OF UNKNOWN ORIGIN COULD BE FOUND. THE OUTER SURFACE OF THE HEAD ADAPTER IS INCONSPICUOUS. REVIEW OF PRODUCT DOCUMENTATION - THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. SEE SURGICAL TECHNIQUE DOC NO. 97-1081-002-00 PRINTED IN USA. ROOT CAUSE ANALYSIS ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT WAS REVISED DUE TO LOOSENING. FOLLOWING OBSERVATION WERE ALSO REPORTED: CUP WAS GROSSLY LOOSE. IT IS ALSO REPORTED THAT THE PATIENT IS ALLERGIC/HYPERSENSITIVE TO NICKEL. THE RETRIEVALS EXHIBIT LACK OF BONE ON GROWTH AND SOME SLIGHTLY POLISHED AREAS ON THE POROUS COATING OF THE DUROM ACETABULAR COMPONENT, WHICH IS CONSISTENT WITH THE REPORTED LOOSENING. SOME SURFACE CHANGES DUE TO FRETTING CORROSION WERE FOUND ON THE INNER SURFACE OF THE HEAD ADAPTER SURFACE. THE REASON FOR THESE PHENOMENA STAYS UNKNOWN. CONCLUSION SUMMARY NO FURTHER INVESTIGATION REQUIRED AS THIS ISSUE IS KNOWN AND ADDRESSED IN (ERROR PATTERN: POTENTIAL EARLY REVISION OF THE ACETABULAR COMPONENT DUE TO LOOSENING, IMPLANT MIGRATION OR UNRESOLVED PAIN, HIGHER ION RELEASE). AT LEAST ONE OF THESE ERROR PATTERNS IS OBSERVED IN THIS EVENT. SHOULD ANY ADDITIONAL INFORMATION THAT CHANGES THE ASSESSMENT BECOME AVAILABLE TO US, OR ANY EXTRA DEMAND BE REQUESTED, WE WILL REEVALUATE THE CASE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4) .

    Description of Event or Problem · 1

    THE PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM ARISING OUT OF THE USE OF THE DUROM ACETABULAR CUP. IT WAS REPORTED THAT THE PATIENT RECEIVED A DUROM ACETABULAR COMPONENT ON AN UNKNOWN DATE. THE PATIENT IS CURRENTLY BEING MONITORED DUE TO UNKNOWN REASON. NO OTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55342 DUROM ACETABULAR COMPONENT DUROM HIP GENERIC KWA ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other