BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TM ACETABULAR SHELL WITH MULTI HOLES

    MDR report key: 2347189 · Received November 18, 2011

    Report

    Report Number
    1822565-2011-02558
    Event Type
    Injury
    Date Received
    November 18, 2011
    Date of Event
    April 27, 2009
    Report Date
    October 20, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. IN GENERAL, PT FACTORS THAT MAY AFFECT THE ALLEGED EVENT INCLUDE: HEIGHT/WEIGHT, ACTIVITY LEVEL, AND TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT). ADHERENCE TO REHABILITATION PROTOCOL IS UNK. SURGICAL NOTES STATE THAT DURING THE EXPLORATORY SURGERY OF THE ABSCESS, PURULENT FLUID WAS WITHDRAWN. THE ACCESS CAVITY TRACKED UP TO THE PERITROCHANTERIC REGION. AT THIS POINT IT WAS FELT THAT THE PT WOULD NEED FURTHER INTERVENTION SUCH AS A POSSIBLE REVISION HIP ARTHROPLASTY. BASED ON THE INFO PROVIDED, A DEFINITIVE CAUSE CANNOT BE DETERMINED WITH CERTAINTY. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECS. 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 ADD'L SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER. INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT HAD INTERMITTENT PAIN AND CHRONIC INDURATION OF THE RIGHT THIGH, AND WAS SEEN PERIODICALLY FOR LAB WORK-UP AND ASPIRATION ON UNK DATES. HE PRESENTED TO THE EMERGENCY DEPT WITH ACUTE WORSENING OF RIGHT THIGH PAIN. THE PT UNDERWENT INCISION AND DRAINAGE FOR PAIN AND AN ABSCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TM ACETABULAR SHELL WITH MULTI HOLES KWZ ZIMMER, INC. 60694533

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SELF-TAPPING BONE SCREW: CAT #: 00625006520| CATALOG #: 00630505840, LOT #: 60731106| FEMORAL HEAD: CAT #00801804001, LOT #: 60671178| ALL ZIMMER (B)(4)| SELF-TAPPING BONE SCREW: CAT#: 00625006520| TRILOGY LONGEVITY ACETABULAR LINER:| LOT#: 60740742| LOT #: 60732298