BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER ELEVATED RIM 36 MM I.D. SIZE LL FOR USE WITH 58 MM O.D. SIZE LL SHELL

    MDR report key: 7947891 · Received October 9, 2018

    Report

    Report Number
    0001822565-2018-05600
    Event Type
    Injury
    Date Received
    October 9, 2018
    Report Date
    June 27, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK151448
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI#: (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT 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 PRODUCT REMAINS IMPLANTED. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 00786401420, ITEM NAME: FEMORAL STEM PRESS-FIT, LOT #: 63207151. ITEM NUMBER: 00875705801, ITEM NAME: SHELL WITH CLUSTER HOLES, LOT #: 632383,50. ITEM NUMBER: 00877503602, ITEM NAME: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14, LOT #: 2924385. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2018 - 05599, 0001822565 - 2018 - 05601. 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 PATIENT IS EXPERIENCING SEVERE PAIN, BALANCE, VISION IMPAIRED, HEARING IMPAIRMENT, WEAK, SEVERE GROIN PAIN, EXTREME PAIN WHERE INCISION, INSTABILITY AND LIMITED MOBILITY POST-IMPLANTATION. THERE HAS BEEN NO REPORTED INTERVENTION AT THIS POINT. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789872 LINER ELEVATED RIM 36 MM I.D. SIZE LL FOR USE WITH 58 MM O.D. SIZE LL SHELL PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 63145338

    Patients

    Seq Age Sex Outcome Treatment
    1 Other