BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER 10 DEGREE ELEVATED RIM 3.5 MM OFFSET 36 MM I.D.

    MDR report key: 18687811 · Received February 12, 2024

    Report

    Report Number
    0001822565-2024-00491
    Event Type
    Injury
    Date Received
    February 12, 2024
    Date of Event
    February 7, 2024
    Report Date
    April 10, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024124813
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER: (B)(4) PONCE.

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: AUSTRALIA. D10: CAT# 65620005821, LOT# 63382517, SHELL POROUS WITHOUT HOLES 58 MM O.D. CAT# 00811400410, LOT# 63724908, FEMORAL STEM 12/14 NECK TAPER. CAT# 4000-8775-036-04, LOT# 2890293, DELTA CERANIC FEM HEAD + 7 36MM. CAT# 00801102028, LOT# 63862008, ALLEN MEDULLARY CEMENT PLUGS. 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.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER 2648920 PONCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 4 YEARS POST IMPLANTATION OF A RIGHT TOTAL HIP ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO DISLOCATION. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426171 LINER 10 DEGREE ELEVATED RIM 3.5 MM OFFSET 36 MM I.D. PROTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 63417809 00889024124813

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Hospitalization| R