BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 56 MM O.D. SHELL

    MDR report key: 8237533 · Received January 10, 2019

    Report

    Report Number
    0001822565-2019-00106
    Event Type
    Injury
    Date Received
    January 10, 2019
    Date of Event
    December 3, 2018
    Report Date
    October 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K002960
    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

    THE INITIAL WAS SUBMITTED UNDER A WRONG MANUFACTURING SITE. THIS REPORT SHOULD BE VOIDED, AS IT WAS SUBMITTED IN ERROR. AN UPDATED REPORT WILL BE SUBMITTED UNDER THE CORRECTED MANUFACTURING SITE.

    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 (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER:0106010003 LOT NUMBER:4023402 BRAND NAME: AVENIR MULLER STEM, CATALOG NUMBER:00620005622 LOT NUMBER:62653713 BRAND NAME: SHELL POROUS WITH CLUSTER, CATALOG NUMBER:00625006535 LOT NUMBER:62754329 BRAND NAME: BONE SCREW, CATALOG NUMBER:00801803602 LOT NUMBER:62715667 BRAND NAME: COCR HEADS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2019-00105. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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 THAT THE PATIENT WAS REVISED DUE TO PAIN APPROXIMATELY 3 MONTHS POST IMPLANTATION. METALLOSIS AND IMPLANT WEAR WAS NOTED DURING THE REVISION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27541 LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 56 MM O.D. SHELL PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 62718393

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R