BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY LONGEVITY CROSSLINKED POLY LINER, PROSTHESIS HIP

    MDR report key: 4797718 · Received May 26, 2015

    Report

    Report Number
    1822565-2015-00763
    Event Type
    Injury
    Date Received
    May 26, 2015
    Date of Event
    April 21, 2015
    Report Date
    November 5, 2020
    Manufacturer
    ZIMMER INC
    Product Code
    LPH
    PMA / PMN Number
    K990135
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROVIDED PRIMARY OPERATIVE SURGERY NOTES; MEDICAL NOTES, LABELS AND LABORATORY REPORTS WERE UNCLEAR. NO ADDITIONAL INFO COULD BE ASCERTAINED. PT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNK. ADHERENCE TO REHABILITATION PROTOCOL IS UNK. CAUSE CANNOT BE DEFINITIVELY DETERMINED. NO DEVICES WER RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNK. BASED ON REVIEW OF THE IMAGES PROVIDED THE LINER WAS DAMAGED. THE CONDITION OF THE INTERNAL HEAD TAPER IS UNCLEAR FROM THE IMAGES. 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.

    Additional Manufacturer Narrative · 1

    REVISION OPERATIVE SURGICAL NOTES WERE NOT PROVIDED; THE CONDITION OF THE STEM COULD NOT BE DETERMINED. THE STEM WAS NOT RETURNED FOR FURTHER EVALUATION AS THIS REMAINS IMPLANTED. DEVICE HISTORY RECORDS FOR THE LOT CODE ASSOCIATED WITH THE STEM WERE REVIEWED. NO DEVIATIONS OR ANOMALIES WERE NOTED IN THE MANUFACTURING PROCESS. NO COMPLAINTS HAVE BEEN RECEIVED AGAINST THE STEM'S MANUFACTURING LOT. THE PRIMARY OPERATIVE NOTES FOR PROCEDURE PERFORMED ON (B)(6) 2009 WERE REVIEWED. THE SURGEON STATED EXCELLENT PRESS-FIT STABILITY OF THE STEM AND FIXATION OF THE SHELL AND LINER, AS WELL AS EXCELLENT STABILITY AND RANGE OF MOTION OF THE CONSTRUCT, WITH APPROPRIATE ABDUCTOR TENSION. THE SURGEON STATED THAT LEG LENGTH COMPLIED WITH THE TEMPLATING. REVIEW OF MEDICAL NOTES FROM PATIENT VISIT ON (B)(6) 2015 INDICATES THAT PATIENT HAD A PREVIOUS DISLOCATION AND CONTINUED NUMBNESS AND INSTABILITY. MRI PERFORMED SHOWED EVIDENCE OF ANTERIOR FLUID COLLECTION, TRACKING ALONG THE ANTERIOR GREATER TROCHANTER. LAB REPORTS INDICATED ELEVATED COBALT LEVELS. IT COULD NOT BE CONFIRMED IF THE PREVIOUS EVENT OF DISLOCATION CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE INFORMATION PROVIDED, A PROBABLE CAUSE FOR THE REPORTED CONDITION IS POTENTIAL CORROSION OF THE HEAD TO NECK JUNCTION.

    Description of Event or Problem · 1

    IT IS REPORTED THE PT WAS REVISED DUE TO AN ADVERSE TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340758 TRILOGY LONGEVITY CROSSLINKED POLY LINER, PROSTHESIS HIP PROSTHESIS, HIP LPH ZIMMER INC 61106334

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention LOT #61111778, MANUFACTURED BY B.V., PONCE, PR.| M/L TAPER STEM: CAT #00771100710, LOT #60765902| VERSYS FEMORAL HEAD, CATALOG #00801803202,| LOT #61111778, MANUFACTURED BY B.V., PONCE, PR.