BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY ACETABULAR SYSTEM LINER

    MDR report key: 2210634 · Received August 10, 2011

    Report

    Report Number
    1822565-2011-01840
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    May 25, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A HEALTH PROFESSIONAL WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THE DEVICES WERE IN VIVO APPROXIMATELY 11.5 YEARS. THE OPERATIVE REPORT FROM WHEN THE HEAD AND LINER WERE IMPLANTED WAS REVIEWED AND DID NOT NOTE ANY COMPLICATIONS. THE REVISION NOTES REPORTED POLYETHYLENE WEAR WITH EARLY OSTEOLYSIS OF THE SUPERIOR ACETABULUM. 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. IN GENERAL, PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF THE ACETABULAR LINER AND FEMORAL HEAD DUE TO POLYETHYLENE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR SYSTEM LINER LPH ZIMMER, INC. 57987900

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention CATALOG #00801802803, LOT #18149700| VERSYS HIP SYSTEM FEMORAL HEAD| (B)(4)