BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, 40/0, TAPER 12/14

    MDR report key: 13306558 · Received January 20, 2022

    Report

    Report Number
    0009613350-2022-00037
    Event Type
    Injury
    Date Received
    January 20, 2022
    Date of Event
    April 1, 2021
    Report Date
    February 3, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    UDI-DI
    00889024430402
    PMA / PMN Number
    K071535
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL PRODUCT: BIOLOX® DELTA TAPER LINER KK / 40; CATALOG#: 00-8775-012-40 ; LOT#: 2523976. SHELL WITH CLUSTER HOLES POROUS 56 MM O.D. SIZE KK FOR USE WITH KK LINERS CATALOG#: 00-8757-056-01 ; LOT#: 61629493. FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 12.5 STANDARD OFFSET; CATALOG#: 65771101200 ; LOT#: 61595725. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. 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). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2022-00038. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SCIATICA FOR 3 MONTHS WHICH WAS TREATED CONSERVATIVELY. IMPLANTS REMAIN IMPLANTED. THIS CASE IS NOT CONSIDERED ANYMORE AS A COMPLAINT. PLEASE INVALIDATE THIS CASE FROM YOUR RECORDS. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND 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

    IT WAS REPORTED THAT THE PATIENT HAS PAIN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SCIATICA FOR 3 MONTHS WHICH WAS TREATED CONSERVATIVELY. IMPLANTS REMAIN IMPLANTED. THIS CASE IS NOT ANYMORE CONSIDERED AS A COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490129 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, 40/0, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2525736 00889024430402

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Hospitalization SEE H10 NARRATIVE