BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XLPE LINER

    MDR report key: 9991764 · Received April 23, 2020

    Report

    Report Number
    0002648920-2020-00236
    Event Type
    Injury
    Date Received
    April 23, 2020
    Date of Event
    December 31, 2019
    Report Date
    April 23, 2020
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    UDI-DI
    00889024123762
    PMA / PMN Number
    K002960
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER: 00620205420 LOT NUMBER: UNKNOWN BRAND NAME: TM MODULAR CUP, FEMORAL HEAD - PART NUMBER 01.25.031, LOT NUMBER 182513 UNKNOWN STEM. REPORT SOURCE: (B)(6). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING PATIENT UNDERWENT A PREVIOUS REVISION ALONG WITH TWO CLOSED REDUCTIONS FOR DISLOCATION. PATIENT CONTINUED TO DISLOCATE AND UNDERWENT A HIP REVISION WHERE THE CUP WAS FOUND TO BE LOOS. A FRACTURE OF THE GREATER TROCHANTER WAS ALSO NOTED DURING THE PROCEDURE. DHR WAS UNABLE TO BE REVIEWED AND THE LOT NUMBER FOR THE DEVICE IS UNKNOWN. THE ROOT CAUSE IS UNABLE TO BE DETERMINED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2020-00352. 0001822565-2020-00353. 0001822565-2020-00354. 0001822565-2020-00355. 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 RECURRENT DISLOCATION AND ACETABULAR CUP LOOSENING. IT WAS NOTED THAT A TROCHANTER FRACTURE WAS NOTED TO HAVE OCCURRED PRIOR TO REVISION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456271 XLPE LINER PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 64036969 00889024123762

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R