BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD MOD HD 38MM -6 NK

    MDR report key: 9937947 · Received April 8, 2020

    Report

    Report Number
    3002806535-2020-00230
    Event Type
    Injury
    Date Received
    April 8, 2020
    Date of Event
    February 25, 2020
    Report Date
    July 16, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    UDI-DI
    05019279316144
    PMA / PMN Number
    K192683
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MANUFACTURER FOR THIS PRODUCT (ITEM: 12-115130). THIS PRODUCT WILL BE REPORTED BY MEDWATCH FACILITY WARSAW BIOMET ¿ (B)(4).

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED BY CLINICAL STUDY FOR EU11 CERAMIC-ON-METAL V MOM USING M2A-38 CUP IN CEMENTLESS THA (339) THAT THE PATIENT INITIALLY UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED ON DUE TO PSEUDOTUMORS AND INFECTION. THE PATIENT WAS THEN REMOVED FROM THE STUDY DUE TO REVISION OF COMPONENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. FOREIGN REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT HAS BEEN DISCARDED BY THE HOSPITAL. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT BI-METRIC HAP 12X140 MM, CATALOG #: 162032, LOT #: 1772937. MEDICAL PRODUCT:-M2A-38 CUP NON FLARED SZ 52MM, CATALOG #: 15-106052, LOT #: 143810. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00231. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED BY CLINICAL STUDY FOR EU11 CERAMIC-ON-METAL V MOM USING M2A-38 CUP IN CEMENTLESS THA (339) THAT THE PATIENT INITIALLY UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED ON DUE TO PSEUDOTUMORS AND INFECTION. THE PATIENT WAS THEN REMOVED FROM THE STUDY DUE TO REVISION OF COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402378 CER BIOLOXD MOD HD 38MM -6 NK HIP PROTHESIS LPH BIOMET UK LTD. N/A 1620263 05019279316144

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE - H10