BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER ACETABULAR COMPONENT

    MDR report key: 2023245 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00634
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    October 2, 2002
    Report Date
    February 14, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: OP NOTES FROM WHEN THE IMPLANTS WERE IMPLANTED AS WELL AS REMOVED WERE RETURNED FOR REVIEW. THE INITIAL SURGERY WENT WELL ALTHOUGH IT WAS NOTED THAT THE PATIENT HAD SOME SCAR TISSUE IN THE ACETABULUM. WHEN THE PATIENT WAS REVISED, IT WAS NOTED THAT THE ACETABULAR COMPONENT DID NOT CONTAIN ANY TISSUE INGROWTH. IT IS NOT KNOWN AT THIS TIME IF THE PRODUCTS IMPLANTED WERE ZIMMER PRODUCTS. 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, ACTIVITY LEVEL, TYPE OF ACTIVITY ARE UNKNOWN. IT IS UNKNOWN IF THE PATIENT'S PREVIOUS PELVIC CONDITION HAD AN EFFECT ON TISSUE INGROWTH INTO THE ACETABULAR COMPONENT. THERE IS INSUFFICIENT INFORMATION TO PERFORM A PROBABLE CAUSE ANALYSIS. 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 INVESTIGATION, 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 WAS REVISED DUE TO LOOSENING OF THE ACETABULAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER ACETABULAR COMPONENT HIP PROSTHESIS KWA ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention