BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, 32/+3.5, TAPER 12/14

    MDR report key: 14235452 · Received April 28, 2022

    Report

    Report Number
    0009613350-2022-00259
    Event Type
    Injury
    Date Received
    April 28, 2022
    Date of Event
    March 30, 2022
    Report Date
    July 25, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    UDI-DI
    00889024430334
    PMA / PMN Number
    K071535
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: AVENIR® MÜLLER, STEM, LATERAL, UNCEMENTED, HA, 4, TAPER 12/14 CATALOG#: 01.06010.104; LOT#: 2893093. 32MM I.D. SIZE II ELEVATED RIM LINER USE WITH 52MM O.D. SIZE II SHELL CATALOG#: 00-8752-010-32 ; LOT#: 63648275. 52MM O.D. SIZE II POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH II LINERS CATALOG#: 00-8757-052-01; LOT#: 63719117. X-RAY RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. 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). DISCARDED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AS NO PRODUCT WAS RETURNED, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT IDENTIFY ANY DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. DEVICE IS USED FOR TREATMENT. THERE ARE NO RECALLS OR PRODUCT HOLDS FOR THE REPORTED PRODUCT. MEDICAL RECORDS WERE NOT PROVIDED AND THE RADIOGRAPH DOES NOT CONFIRM REPORTED EVENT.. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: TOTAL HIP REPLACEMENT ON RIGHT HIP DONE IN (B)(6) HOSPITAL. REASON FOR REVISION IS DISLOCATION.PATIENT INVOLVEMENT-REVISION.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196845 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, 32/+3.5, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2924380 00889024430334

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention| H SEE H10 NARRATIVE.