BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14

    MDR report key: 8178259 · Received December 19, 2018

    Report

    Report Number
    0009613350-2018-01276
    Event Type
    Injury
    Date Received
    December 19, 2018
    Date of Event
    December 10, 2018
    Report Date
    July 5, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024430327
    PMA / PMN Number
    K071535
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. ADDITIONAL AND CORRECTED INFORMATION ARE FILLED IN THE FOLLOWING FIELDS: PLEASE BE AWARE THAT THIS COMPLAINT: (B)(4) IT IS A DUPLICATE OF THE COMPLAINT: (B)(4)(SUBMITTED WITH THE REFERENCE: 0009613350-2019-0001) AND IT WILL BE SET TO NOT A COMPLAINT. PLEASE DELETE THIS REPORT FROM YOUR DATABASE. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    PLEASE BE AWARE THAT THIS COMPLAINT: (B)(4) IT IS A DUPLICATE OF THE COMPLAINT: (B)(4) (SUBMITTED WITH THE REFERENCE: 0009613350-2019-0001) AND IT WILL BE SET TO NOT A COMPLAINT. PLEASE DELETE THIS REPORT FROM YOUR DATABASE.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT: LINER STANDARD 32 MM I.D. FOR USE WITH 48 MM O.D. SHELL; CATALOG NO#: 00-6305-048-32 ; LOT#: 63697496; SHELL POROUS WITH CLUSTER HOLES 48 MM; CATALOG NO#: 00-6202-048-22 ; LOT#: 63696846; FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 1 130 MM STEM LENGTH; CATALOG NO#: 00-8114-001-10 ; LOT#: 37109689. THERAPY DATE: (B)(6) 2018. THE MANUFACTURER RECEIVED DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON THE LEFT SIDE AND UNDERWENT REVISION SURGERY DUE TO INFECTION AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022071 BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 32/0, TAPER 12/14 BIOLOX DELTA, CERAMIC FEMORAL HEAD LZO ZIMMER GMBH N/A 2897014 00889024430327

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R