BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY LONGEVITY CROSSLINKED POLY LINER

    MDR report key: 2041096 · Received March 29, 2011

    Report

    Report Number
    1822565-2011-00769
    Event Type
    Injury
    Date Received
    March 29, 2011
    Report Date
    February 28, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONDITION OF THE COMPONENTS IS UNK. PHOTOS, SURGICAL NOTES AND 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, AND RELEVANT MEDICAL HISTORY ARE UNK. ADHERENCE TO REHABILITATION PROTOCOL IS UNK. A ROOT CAUSE CANNOT BE DETERMINED. 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 IS REPORTED THAT THE PT IS EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY LONGEVITY CROSSLINKED POLY LINER LPH ZIMMER INC 54018400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ZIMMER BV, PONCE, PR| BONE SCREW SELF-TAPPING: CATALOG #00625006530| VERSYS HIP SYSTEM FEMORAL STEM| CATALOG #65786201600, LOT #51602500| BONE SCREW SELF-TAPPING: CATALOG #00625006535| BONE SCREW SELF-TAPPING: CATALOG #00625006535| LOT #22057700, MFG AT ZIMMER BV, PONCE,PUERTO RICO| TRILOGY ACETABULAR SYSTEM SHELL WITH CLUSTER HOLES| CATALOG #00620005622, LOT #25794200, MFG AT| LOT #23350500, MFG AT ZIMMER BV, PONCE, PR| LOT #25339300, MFG AT ZIMMER BV, PONCE, PR| VERSYS HIP SYSTEM FEMORAL HEAD| CATALOG #00801802801, LOT #23406300, MFG AT| ZIMMER BV, PONCE, PR