BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER HIP

    MDR report key: 3022688 · Received March 22, 2013

    Report

    Report Number
    1822565-2013-00517
    Event Type
    Injury
    Date Received
    March 22, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: PRIMARY OPERATIVE NOTES WERE PROVIDED FOR REVIEW AND NOTE THAT THE PATIENT'S RIGHT HIP DEVELOPED SEPTIC ARTHRITIS PREOPERATIVELY, AND AFTER EXTENSIVE ANTIBIOTIC TREATMENT A SATISFACTORY RESOLUTION OF THE INFECTION WAS VERIFIED. THE SURGICAL NOTES ALSO MENTION THAT OLD SUTURES WERE ENCOUNTERED DURING ENTRY OF THE HIP FROM A PRIOR SURGERY; HOWEVER, NO DETAIL OF THE PRIOR SURGERY IS AVAILABLE. SIGNIFICANT BONE LOSS NECESSITATED THE PLACEMENT OF AN AUGMENT IN CONJUNCTION WITH THE ACETABULAR CUP. IT WAS ALSO NOTED THAT THE SCREW HOLES IN THE AUGMENT WERE NOT IN A SATISFACTORY POSITION AND THEREFORE, THE SURGEON DRILLED AN ADDITIONAL HOLE TO SECURE THE AUGMENT INTO THE ILIUM. WITH THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120581 UNKNOWN ZIMMER HIP HIP PROSTHESIS LZO ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other