BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC HD ARCOM XL 28X50MM

    MDR report key: 4330507 · Received December 15, 2014

    Report

    Report Number
    0001825034-2014-09042
    Event Type
    Injury
    Date Received
    December 15, 2014
    Date of Event
    June 30, 2014
    Report Date
    October 14, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWZ
    PMA / PMN Number
    PK030047
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: ¿DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION, MALALIGNMENT, MALPOSITION, EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, WEIGHT GAIN, OR OBESITY. MUSCLE AND FIBROUS TISSUE LAXITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS.¿ DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS. THIS REPORT IS NUMBER 5 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-08786 & 08799 / 08800 & 09041 / 09043).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY A ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). M2A-MAGNUM PF CUP 56ODX50ID CATALOG US157856 LOT 648020; ECHO FEMORAL 12X14 CATALOG 192012 LOT 963430; ; CERAMIC BIOLOX FEMORAL HEAD CATALOG 650-1055 LOT 929830; CERAMIC TYPE 1 TAPER CATALOG 650-1066 LOT 729930. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION PROCEDURES ON (B)(6) 2014 AND (B)(6) 2014 DUE TO DISLOCATION. PATIENT UNDERWENT A FURTHER REVISION PROCEDURE ON (B)(6) 2014 DUE TO RECURRENT DISLOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SECOND RIGHT HIP REVISION PROCEDURE DUE TO RECURRENT DISLOCATION APPROXIMATELY TWO WEEKS AFTER THE INITIAL REVISION. THE FEMORAL HEAD, TAPER ADAPTER AND ACETABULAR COMPONENTS WERE REMOVED AND REPLACED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820861 ACT ARTIC HD ARCOM XL 28X50MM PROSTHESIS, HIP KWZ BIOMET ORTHOPEDICS N/A 233560

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R