BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD MOD HD 28MM STD NK

    MDR report key: 9369238 · Received November 25, 2019

    Report

    Report Number
    3002806535-2019-00895
    Event Type
    Injury
    Date Received
    November 25, 2019
    Date of Event
    July 29, 2018
    Report Date
    November 27, 2019
    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
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A FURTHER REVISION DUE TO INFECTION LESS THAN ONE YEAR POST OPERATIVE. PATIENT WAS WASHED OUT AND THE HEAD AND BEARING COMPONENTS WERE REMOVED AND REPLACE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: ACT ARTIC E1 HIP BRG 28X42MM CATALOG #: EP-200148 LOT #: 006190, MEDICAL PRODUCT: ARCOS CON SZ B STD 70MM CATALOG #: 11-301322 LOT #: UNK, MEDICAL PRODUCT: MOD FEMORAL PROX LOCKING SCREW CATALOG #: 11-301000 LOT #: 810870, MEDICAL PRODUCT: CABLE CERCLAGE CABLE WITH CRIMP 1.8 MM DIA. 635 MM LENGTH CATALOG #: 00223200418 LOT #: 63989795, MEDICAL PRODUCT: G7 PPS LTD ACET SHELL 52E CATALOG #: 010000663 LOT #: 6289244, MEDICAL PRODUCT: BONE SCR 6.5X35 SELF-TAP CATALOG #: 00625006535 LOT #: 63651675, MEDICAL PRODUCT: G7 DUAL MOBILITY LINER 42MM E CATALOG #: 110024463 LOT #: 690310. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A FURTHER REVISION DUE TO INFECTION LESS THAN ONE YEAR POST OPERATIVE. PATIENT WAS WASHED OUT AND THE HEAD AND BEARING COMPONENTS WERE REMOVED AND REPLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163080 CER BIOLOXD MOD HD 28MM STD NK HIP PROSTHESIS LZO BIOMET UK LTD. N/A 2895349

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R