BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY LONGEVITY LINER

    MDR report key: 2113442 · Received May 31, 2011

    Report

    Report Number
    1822565-2011-01289
    Event Type
    Injury
    Date Received
    May 31, 2011
    Report Date
    May 2, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNK. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFO PROVIDED. EVAL: 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. SHOULD ADDITIONAL 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 WAS REVISED FOR AN UNK REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY LONGEVITY LINER LPH ZIMMER INC 54891000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VERSYS FEMORAL HEAD: CATALOG# 00801802803| LOT# 60059047| VERSYS HIP SYSTEM FEMORAL STEM:| CATALOG# 00786201730, LOT# 60042599| MANUFACTURED BY ZIMMER (B)(4)| CATALOG# 00620006222, LOT# 60069486| TRILOGY SHELL WITH CLUSTER HOLES:| MANUFACTURED BY ZIMMER (B)(4)