BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM ACETABULAR COMPONENT 54/48 N

    MDR report key: 2823667 · Received October 30, 2012

    Report

    Report Number
    9613350-2012-01014
    Event Type
    Injury
    Date Received
    October 30, 2012
    Date of Event
    December 6, 2017
    Report Date
    January 8, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    PMA / PMN Number
    PNA
    Removal / Correction Number
    9613350-07/15/2008-001C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW, AS THE PATIENT IS MONITORED AND HAS NOT BEEN REVISED TO DATE. WHERE LOT NUMBERS WERE RECEIVED FOR THE 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 INFORMATION PROVIDED, AS THE PATIENT HAS NOT BEEN REVISED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE MIGHT BE RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A CORRECTION IN JULY 2008. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). SINCE THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLEMENTED A NOTIFICATION IN JULY 2008 AS REFERENCED, ZIMMER (B)(4) WILL CLOSE THIS CASE ONCE AGAIN. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    AS THE CASE AT HAND IS A LEGAL CLAIM IT IS NOT SUSPECTED THAT THE DEVICES OR ADDITIONAL INFORMATION ARE BEING SUBMITTED FOR REVIEW. ZIMMER GMBH WINTERTHUR LEGAL DEPARTMENT HAVE ALREADY PASSED ALL INFORMATION THAT WAS RECEIVED FROM THE LAWYER, TO OUR COMPLAINT HANDLING DEPARTMENT. BY EXPERIENCE ZIMMER GMBH NEVER GETS MORE INFORMATION EXCEPT FOR THE ONE THAT HAS BEEN ALREADY COVERED IN THE FINAL REPORT. PATIENTS¿ ADVOCATES ONLY PROVIDE TO ZIMMER GMBH AS MUCH INFORMATION AS THEY ARE WILLING TO SHARE TO PROTECT THE RIGHTS OF THEIR CLIENTS. ALL INFORMATION WHICH HAS BEEN PROVIDED FOR THIS PARTICULAR CASE IS ALREADY COVERED IN THE FINAL REPORT. NEVERTHELESS, SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE TO US, A FOLLOW UP REPORT WILL BE SUBMITTED. DHR REVIEW: THE QUALITY RECORDS INDICATE THAT THESE COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REVIEW OF EVENT DESCRIPTION: PATIENT UNDERWENT PLANNED REVISION SURGERY DUE TO UNKNOWN REASONS. REVIEW OF RECEIVED DATA: SURGICAL REPORT : REVIEW OF SURGICAL REPORT DID NOT LEAD TO NEW INFORMATION REGARDING THE REPORTED EVENT. OTHER INFORMATION & SOURCES : REVIEW OF THE COMPLAINT RELEVANT DOCUMENTS DID NOT LEAD TO NEW INFORMATION REGARDING THE REPORTED EVENT. THE RESULT OF THE EXAMINATION DID NOT CHANGE THE RESULTS OF THE PREVIOUS ASSESSMENT IN WHICH ZIMMER IMPLEMENTED A NOTIFICATION IN JULY 2008. THE DISTRIBUTION OF THIS PRODUCT WAS CEASED IN THE MEANWHILE. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON DECEMBER 12, 2017. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN ACETABULAR CUP ON HER LEFT HIP ON (B)(6) 2008. THE PATIENT HAS BEEN HAVING PAIN AND REVISION SURGERY IS BEING DISCUSSED.

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT HAS NOW BEEN REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 54/48 N. THIS IS A BILATERAL CLAIM. RIGHT SIDE CASE: (B)(4).

    Description of Event or Problem · 1

    A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 54/48 N ON THE LEFT SIDE ON (B)(6) 2008. A REVISION SURGERY IS PLANNED FOR (B)(6), 2017 DUE TO UNKNOWN REASON.

    Description of Event or Problem · 1

    IT HAS NOW BEEN REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT 54/48 N. THE PATIENT WAS REVISED ON (B)(6) 2017 DUE TO PAIN, LOOSENING, CYST, FLUID COLLECTION, DEBRIS, PSEUDOTUMOR AND OSTEOLYSIS. THIS IS A BILATERAL CLAIM. RIGHT SIDE COMPLAINT : (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUROM ACETABULAR COMPONENT 54/48 N DUROM ACETABULAR COMPONENT AND METASUL LDH KWA ZIMMER GMBH N/A 2419523

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| O| R