BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOLOX DELTA HEAD 32

    MDR report key: 11723054 · Received April 26, 2021

    Report

    Report Number
    3002806535-2021-00129
    Event Type
    Injury
    Date Received
    April 26, 2021
    Date of Event
    December 7, 2020
    Report Date
    May 19, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00127-1, 3002806535-2021-00128-1. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED FOR ITEM 123952HA. A REVIEW OF THE MANUFACTURING HISTORY RECORDS COULD NOT BE PERFORMED FOR LINER AND HEAD AS THE LOT NUMBERS ARE UNKNOWN. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS FOUND NO OTHER SIMILAR COMPLAINTS REPORTED WITH THE ITEMS 123952HA AND 650-0791. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO MAJOR BONE DESTRUCTION FOLLOWING A MASSIVE METALLOSIS. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT: REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CONCOMITANT MEDICAL PRODUCTS: CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED. MEDICAL PRODUCT: BIOLOX DELTA LNR 32MM 50-52MM CATALOG #650-0791 LOT # UNKNOWN. MEDICAL PRODUCT: EXC ABT STD SHELL HA/PC 052MM CATALOG #123952HA LOT # 2044350. MEDICAL PRODUCT: UNK EXCEPTION FEMORAL COMPONENT CATALOG #UNKNOWN LOT # UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00127, 3002806535-2021-00128.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO MAJOR BONE DESTRUCTION FOLLOWING A MASSIVE METALLOSIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED AS YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624004 UNKNOWN BIOLOX DELTA HEAD 32 HIP PROTHESIS LZO BIOMET UK LTD. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R