BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER EPOCH FEMORAL STEM

    MDR report key: 4092579 · Received September 4, 2014

    Report

    Report Number
    1822565-2014-01074
    Event Type
    Injury
    Date Received
    September 4, 2014
    Report Date
    August 7, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA PUBLISHED LITERATURE. EVALUATION SUMMARY: NEITHER PRIMARY NOR REVISION OPERATIVE NOTES WERE RETURNED FOR REVIEW. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION HOWEVER NO INFORMATION HAS BEEN RECEIVED TO DATE. AN X-RAY AT 3 WEEKS POST-OP OF THE IMPLANT SURGERY SHOWS WELL PLACED COMPONENTS. X-RAYS AT 2 YEARS POST-OP SHOWS STEM SUBSIDENCE AND FRACTURE OF THE POROUS COATING OF THE STEM. INFECTION WAS IDENTIFIED AT THIS POINT AND THE PATIENT WAS REVISED IN A TWO-STAGE REVISION. IN GENERAL, PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS INCLUDE: AGE, BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY AND RELEVANT MEDICAL HISTORY. REHABILITATION PROTOCOL AND ADHERENCE THERETO IS UNKNOWN. WITH THE INFORMATION PROVIDED, THE FAILURE IS LIKELY RELATED TO THE PATIENT'S INFECTION. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: REVIEW OF THE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. 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 AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A TWO-STAGE REVISION DUE TO INFECTION, PAIN, AND FEMORAL SUBSIDENCE. INTRAOPERATIVE FINDINGS SHOWED DELAMINATION OF THE IMPLANT COATING WITH DETACHMENT AND FRAGMENTATION OF THE TITANIUM FIBER METAL MESH AND COMPOSITE FROM THE INNER CORE OF THE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541492 UNKNOWN ZIMMER EPOCH FEMORAL STEM HIP PROSTHESIS LZO ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK ZIMMER SHELL, CATALOG# UNK, LOT# UNK| UNK ZIMMER FEMORAL HEAD, CATALOG# UNK, LOT# UNK