BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER 10 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS

    MDR report key: 7201766 · Received January 17, 2018

    Report

    Report Number
    0001822565-2018-00395
    Event Type
    Injury
    Date Received
    January 17, 2018
    Report Date
    March 23, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK990135
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001822565-2018-00392, 0001822565-2018-00393, 0002648920-2018-00047, 0001822565-2018-00394. CONCOMITANT MEDICAL PRODUCTS: 00784800200 MODULAR NECK K 12/14 NECK TAPER USE WITH +0 HEADS ONLY LOT 61218348, 00771301300 MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS SIZE 13.5 LOT 61375744, 00801803202 FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER LOT 61426909, 65620005422 SHELL POROUS WITH CLUSTER HOLES 54 MM O.D. WITH CALCICOAT CERAMIC COATING LOT 61330651 . THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT IT WAS DETERMINED THAT THIS EVENT WILL BE REPORTED ON MFR NUMBER 1822565-2011-02059-1.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT INITIAL TOTAL HIP ARTHROPLASTY DUE TO DEGENERATIVE ARTHRITIS. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING SEVERE PAIN IN THE GROIN AND TIBIAL AREA. THE PATIENT HAS BEEN DOING ONGOING TREATMENT FOR THIS PAIN WITH MULTIPLE PROCEDURES AND IS REFUSING A REVISION PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46067 LINER 10 DEGREE ELEVATED RIM 32 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH ZIMMER BIOMET, INC. N/A 61365043

    Patients

    Seq Age Sex Outcome Treatment
    1 Other