BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX

    MDR report key: 3042100 · Received April 4, 2013

    Report

    Report Number
    9613350-2013-01477
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    December 17, 2012
    Report Date
    March 26, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT RECEIVED A TOTAL HIP IMPLANT ON (B)(6) 2004, IN HER LEFT HIP. AFTER HAVING A CAR ACCIDENT RESULTING IN A 2 DEGREES OPEN PERIPROSTHETIC FRACTURE OF THE FEMUR (LEFT) A PLATE OSTEOSYNTHESIS WAS PERFORMED ON (B)(6), 2012. THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2012. THE REASON WAS THAT SHE HEARD NOISES 2 WEEKS AFTER HER REHABILITATION PROGRAM, WHICH MORE AND MORE APPEARED TO HAVE A CRACKING SOUND WHICH ANNOYED THE PATIENT. THERE WERE NO MASSIVE PAIN SYMPTOMS. THE INVESTIGATION SHOWED THAT THERE WAS A MASSIVE CRACKING NOISE IN THE LEFT HIP WHILE MOVING THE LEG. THERE WAS ALSO A SHORTENING OF THE LEG OF ABOUT 1 CM. X-RAYS SHOWED A BREAKAGE OF THE CERAMIC BALL HEAD. DURING SURGERY, WHICH WAS PERFORMED ON (B)(4) 2012, THE CERAMIC BALL HEAD APPEARED TO BE COMPLETELY DESTROYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139267 BIOLOX BIOLOX LZO ZIMMER GMBH 2219944

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R