BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHELL WITH CLUSTER HOLES POROUS 46 MM

    MDR report key: 10106742 · Received June 1, 2020

    Report

    Report Number
    0001822565-2020-01929
    Event Type
    Injury
    Date Received
    June 1, 2020
    Date of Event
    May 7, 2020
    Report Date
    July 17, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024150119
    PMA / PMN Number
    K151448
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ET
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER:00875100728, LOT NUMBER:64165957, BRAND NAME: ACETABULAR LINER. CATALOG NUMBER:163660, LOT NUMBER: J6303568, BRAND NAME: COCR HEAD. CATALOG NUMBER: 21-103202, LOT NUMBER: 6252580, BRAND NAME: TAPERLOC FEMORAL STEM . MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2020-01928. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN INITIAL HIP SURGERY. APPROXIMATELY 2 WEEKS POST IMPLANTATION, THE PATIENT BEGAN EXPERIENCING DRAINAGE FROM THE WOUND. AN IRRIGATION AND DEBRIDEMENT PROCEDURE WAS PERFORMED. A FEW DAYS LATER, THE PATIENT DISLOCATED THE HIP AND WAS REVISED. THE ASSUMPTION OF A DEEP INFECTION WAS REPORTED. THE LINER WAS REVISED, WHICH WAS VISIBLY DELAMINATING. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568531 SHELL WITH CLUSTER HOLES POROUS 46 MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64326501 00889024150119

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| O SEE H10 NARRATIVE.