BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONGEVITY HIGHLY CROSSLINKED POLYETHYLENE OBLIQUE LINER

    MDR report key: 8692425 · Received June 12, 2019

    Report

    Report Number
    0001822565-2019-02387
    Event Type
    Injury
    Date Received
    June 12, 2019
    Date of Event
    November 10, 2018
    Report Date
    August 23, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K103662
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. MEDICAL NOTES WERE REVIEWED AND IDENTIFIED PATIENT EXPERIENCED A DISLOCATION OF THE RIGHT HIP PROSTHESIS REQUIRING A CLOSED REDUCTION UNDER CONSCIOUS SEDATION. ANOTHER MEDICAL NOTE IDENTIFIED PATIENT EXPERIENCED A SECOND DISLOCATION OF THE RIGHT HIP PROSTHESIS. A TOTAL RIGHT HIP PROSTHESIS IS DISLOCATED WITH THE FEMORAL COMPONENT DISPLACED SUPERIORLY. DEVICE HISTORY RECORD (DHR) 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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. UDI NUMBER - (B)(4). CONCOMITANT MEDICAL PRODUCTS: PART: 00877703204, BIOLOX® OPTION, HEAD, XL, ø 32/+7, TAPER 12/14, LOT: 2927640. PART: 00875704802, SHELL WITH MULTI HOLES POROUS 48 MM O.D. SIZE GG, LOT: 61448860. PART: 00784301106, FEMORAL STEM BEADED FULLCOAT 12/14 NECK TAPER, LOT: 60732009. PART: 010001001, G7 SCREW 6.5 MM X 40 MM, LOT: 6033599.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION AND SUBSEQUENTLY, EIGHT MONTHS LATER THE PATIENT EXPERIENCED A SECOND DISLOCATION OF THE RIGHT HIP PROSTHESIS. NO FURTHER TREATMENT OR INTERVENTION INFORMATION AVAILABLE AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486837 LONGEVITY HIGHLY CROSSLINKED POLYETHYLENE OBLIQUE LINER PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 63635189

    Patients

    Seq Age Sex Outcome Treatment
    1 Other