BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX OPTION HD/ADPT, 12/14, 40 X -3.0

    MDR report key: 4741927 · Received April 30, 2015

    Report

    Report Number
    9613350-2015-00493
    Event Type
    Injury
    Date Received
    April 30, 2015
    Date of Event
    December 10, 2012
    Report Date
    December 20, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PK073567
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON JULY 31, 2015 AND THIS CASE WAS RE-OPENED. THE OP REPORTS WERE SUBMITTED . THE REVIEW OF THE INFORMATION PROVIDED DID NOT LEAD TO A NEW CONCLUSION. ZIMMER (B)(4) CONSIDERS ONCE AGAIN THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4). THIS IS A SPLIT CASE WITH ZIMMER INC., (B)(4) REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THE ROUTER AND INCOMING RECEIPT HAVE BEEN REVIEWED. NO TREND WAS IDENTIFIED. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER. POSSIBLE ROOT CAUSES: NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS AGE, BONE QUALITY, HEIGHT/WEIGHT, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. BESIDES IT CAN BE SAID THAT THE FAILURE DID NOT ORIGINATE DUE TO A PROBLEM OF THE FEMORAL HEAD. HOWEVER ALL POSSIBLE FAILURE MODES, POTENTIAL CAUSES AND RISKS RELATED TO BIOLOX HEAD ARE COVERED IN DFMEA. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED AS THE ALLEGED FAILURE COULD NOT BE IDENTIFIED OR REPRODUCED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4). THIS IS A SPLIT CASE WITH ZIMMER INC., (B)(4) REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES OR X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. DUE TO FACT THAT THIS IS A LEGAL CLAIM, OUR LEGAL DEPARTMENT HAS BEEN PROVIDED WITH THE AVAILABLE FACTS FROM THE CUSTOMER. ZIMMER (B)(4) LEGAL DEPARTMENT IS WELL TRAINED AND PASSES ALL INFORMATION CONCERNING THE CASE TO OUR COMPLAINT HANDLING DEPARTMENT. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. 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 CONTINUUM AND BIOLXO PRODUCTS. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A BIOLOX OPTION HD/ADPT, 12/14, 40 X -3.0 ON (B)(6) 2011. THE PATIENT WAS REVISED ON (B)(6) 2012 TO REPLACE THE SHELL, HEAD, AND LINER DUE TO LOOSENING. THE FIRST REVISION SURGERY IS TREATED IN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284428 BIOLOX OPTION HD/ADPT, 12/14, 40 X -3.0 BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES LZO ZIMMER GMBH NA 2409129

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R