BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XLPE LINER STANDARD

    MDR report key: 8560725 · Received April 29, 2019

    Report

    Report Number
    0002648920-2019-00315
    Event Type
    Injury
    Date Received
    April 29, 2019
    Date of Event
    December 5, 2016
    Report Date
    April 29, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K990135
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). M / L TAPER G2 MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED # ITEM 00771301100 LOT 63161443, KINECTIV MODULAR NECK # ITEM 00784803300 LOT 63151229, BIOLOX® DELTA, CERAMIC FEMORAL HEAD # ITEM 00877503202 LOT 2801912, TM SHELL POROUS WITH CLUSTER HOLES # ITEM 00620205022 LOT 63146874. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2018-05135 AND 0001822565-2018-05137. REPORTED EVENT WAS CONFIRMED BY REVIEW OF REVISION OP NOTES. OP-NOTES OF REVISION SURGERY STATED THAT PATIENT UNDERWENT REVISION OF RIGHT TOTAL HIP REPLACEMENT DUE TO PAIN AND FAILED ATTEMPTS AT CONSERVATIVE THERAPY. THE PATIENT WAS WORKED UP FOR POSSIBLE METALLOSIS. HOWEVER, NO EVIDENCE OF METALLOSIS WAS NOTED DURING THE PROCEDURE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN APPROXIMATELY 13 MONTHS POST INITIAL SURGERY. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353526 XLPE LINER STANDARD PROSTHESIS HIP LPH ZIMMER MANUFACTURING B.V. N/A 63152961

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R