BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINECTIV MODULAR NECK

    MDR report key: 7891216 · Received September 19, 2018

    Report

    Report Number
    0001822565-2018-05137
    Event Type
    Injury
    Date Received
    September 19, 2018
    Date of Event
    December 5, 2016
    Report Date
    April 29, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK063251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI - (B)(4). 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 CONSEVATIVE 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: M / L TAPER G2 MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED, # ITEM 00771301100, LOT 63161443; XLPE LINER STANDARD, # ITEM 00630505032, LOT 63152961; 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 0001822565-2018-05136. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN APPROXIMATELY 13 MONTHS POST INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733087 KINECTIV MODULAR NECK PROSTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 63151229

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R