BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14

    MDR report key: 10166832 · Received June 18, 2020

    Report

    Report Number
    0009613350-2020-00265
    Event Type
    Injury
    Date Received
    June 18, 2020
    Date of Event
    May 19, 2020
    Report Date
    February 16, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    UDI-DI
    00889024430365
    PMA / PMN Number
    K071535
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE HAS BEEN MOVED TO THE ASSOCIATED PRODUCTS AND THE MAIN PRODUCT IS NOT DISTRIBUTED/RELASED IN USA. PLEASE DELETE THIS REPORT FROM YOUR RECORDS. ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    THIS DEVICE HAS BEEN MOVED TO THE ASSOCIATED PRODUCTS AND THE MAIN PRODUCT IS NOT DISTRIBUTED/RELASED IN USA. PLEASE DELETE THIS REPORT FROM YOUR RECORDS.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT: SHELL WITH UNI-HOLE POROUS 54 MM O.D. SIZE JJ FOR USE WITH JJ LINERS; ITEM#00875705400; LOT#64447909. AVENIR MUELLER, STEM, STANDARD, UNCEMENTED, HA, 3, TAPER 12/14; ITEM#0106010003; LOT#3008040. THE MANUFACTURER DID NOT RECEIVE X-RAYS FOR REVIEW. SURGICAL REPORTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE YET THE DEVICE, HOWEVER IT IS INDICATED BY COMPLAINANT THAT IT WILL BE RETURNED FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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 AN UNKNOWN SIDE AND UNDERWENT REVISION DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634082 BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3019515 00889024430365

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R SEE H10 NARRATIVE