BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUROM US ACET CMPNT

    MDR report key: 3946352 · Received July 10, 2014

    Report

    Report Number
    9613350-2014-03703
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    April 16, 2012
    Report Date
    March 13, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS OR OTHER SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. WHILE A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED, THE COMMON CLINICAL PRESENTATION AND THE DATE OF THE ORIGINAL IMPLANTATION SUGGEST THAT THIS CASE IS RELATED TO THE ISSUES FOR WHICH ZIMMER IMPLANTED A NOTIFICATION IN 07/2008 AS REFERENCED ABOVE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BECOMES AVAILABLE THAT CHANGES THIS ASSESSMENT, 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

    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 (B)(4) LEGAL DEPARTMENT HAVE ALREADY PASSED ALL INFORMATION THAT WAS RECEIVED FROM THE LAWYER, TO OUR COMPLAINT HANDLING DEPARTMENT. BY EXPERIENCE ZIMMER (B)(4) NEVER GETS MORE INFORMATION EXCEPT FOR THE ONE THAT HAS BEEN ALREADY COVERED IN THE FINAL REPORT. PATIENTS¿ ADVOCATES ONLY PROVIDE TO ZIMMER (B)(4) 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. A TECHNICAL INVESTIGATION WAS NOT POSSIBLE TO BE PERFORMED, AS THE DEVICE(S) WERE NOT AT HAND FOR INVESTIGATION. HOWEVER, BASED ON THE AVAILABLE INFORMATION THE INVESTIGATION IS CONDUCTED WITH OUTCOME AS FOLLOWS. DHR REVIEW RESULTS: DHR RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. TREND ANALYSIS: TREND HAS BEEN IDENTIFIED AND CAPA WAS INITIATED AND PERFORMED. REVIEW OF EVENT DESCRIPTION: PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION AND PAIN. 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. CONCLUSION: THE STERILIZATION PROCESS FOR THESE DEVICES WAS VALIDATED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL (SAL) OF 1.0 X 10-6 OR BETTER. IT IS HIGHLY UNLIKELY THAT THE SPECIFIED DEVICE CAUSED OR CONTRIBUTED TO THE INFECTION OF THE PATIENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND / OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BECOMES AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM ACETABULAR COMPONENT ON THE LEFT SIDE ON (B)(6) 2008. THE PATIENT WAS REVISED ON (B)(6) 2009 DUE TO UNKNOWN REASONS.

    Description of Event or Problem · 1

    A PRODUCT LIABILITY CLAIM WAS RAISED. IT HAS NOW BEEN REPORTED THAT THE PATIENT WAS IMPLANTED A DUROM US ACET CMPNT 56/50 P ON THE LEFT SIDE ON (B)(6) 2009. THE PATIENT UNDERWENT A REVISION SURGERY DUE TO INFECTION ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404442 DUROM US ACET CMPNT DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS KWA ZIMMER GMBH N/A 2430319

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R