BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY LONGEVITY CROSSLINKED POLY LINER

    MDR report key: 1934169 · Received December 8, 2010

    Report

    Report Number
    1822565-2010-01304
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Report Date
    November 11, 2010
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: SURGICAL NOTES OR X-RAYS WERE NOT PROVIDED. IT IS UNK WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION PER THE APPLICABLE SURGICAL TECHNIQUES. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS AGE, HEIGHT/WEIGHT, BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY, REHABILITATION PROTOCOL BOTH PHYSIOLOGICAL AND PHARMACEUTICAL AND COMPLIANCE THEREOF ARE UNK. BASED ON THE ABOVE INFO, THE CAUSE OF THE LACK OF RANGE OF MOTION FOR THE PT IS UNK. 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 ADD'L SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT IS PRESENTING WITH LIMITED RANGE OF MOTION WHILE LYING DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY LONGEVITY CROSSLINKED POLY LINER HIP PROSTHESIS LPH ZIMMER 61369486

    Patients

    Seq Age Sex Outcome Treatment
    1 MANUFACTURED BY ZIMMER (B)(4)| LOT #61346689 - MANUFACTURED BY ZIMMER (B)(4)| LOT #61431804| VERSYS FEMORAL HEAD, CATALOG #00801803602,| KINECTIV MODULAR NECK, CATALOG #00784801200,| CATALOG #65771301100, LOT #61202994| ZIMMER M/L MODULAR FEMORAL STEM,