BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUS RNGLC II CONST LNR 22X32+5

    MDR report key: 4408916 · Received January 12, 2015

    Report

    Report Number
    0001825034-2015-00140
    Event Type
    Injury
    Date Received
    January 12, 2015
    Date of Event
    November 23, 2014
    Report Date
    January 16, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PCUSTOM
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. ALTHOUGH NO ROOT CAUSE FOR THE DISLOCATION COULD BE DETERMINED, IT WAS REPORTED THAT CONDITIONS WERE CONSISTENT WITH PATIENT NONCOMPLIANCE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. UNDER POSSIBLE ADVERSE EFFECTS, IT STATES: DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION, MALALIGNMENT, MALPOSITION, EXCESSIVE, UNUSUAL AND/OR AWKWARD MOVEMENT AND/OR ACTIVITY, TRAUMA, WEIGHT GAIN, OR OBESITY." THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-08005-2 & 2015-00140 /-00141).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED REPORTS THE PATIENT WAS REVISED DUE TO DISLOCATION AND A CUSTOM CONSTRAINED LINER WAS IMPLANTED (B)(6) 2014. IT WAS FURTHER REPORTED THAT THE PATIENT DISLOCATED A FEW WEEKS LATER AND UNDERWENT A SUBSEQUENT REVISION PROCEDURE ON (B)(6) 2014. ALL COMPONENTS WERE REMOVED AND A SECOND CUSTOM LINER AND RETAINING RING WERE REPLACED. BEFORE THE END OF THE PROCEDURE, THE NEW LINER AND CUP WERE REMOVED DUE TO ARTICULATION ISSUES AND REPLACED WITH COMPETITOR PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION AND A CUSTOM CONSTRAINED LINER WAS IMPLANTED ON (B)(6) 2014. IT WAS FURTHER REPORTED THAT THE PATIENT DISLOCATED A FEW WEEKS LATER AND UNDERWENT A SUBSEQUENT REVISION PROCEDURE ON (B)(6) 2014. ALL COMPONENTS WERE REMOVED AND THE SURGEON ATTEMPTED TO REUSE THE SAME CUSTOM LINER, NOT A NEW SECOND CUSTOM LINER, ALONG WITH A NEW LOCKING RING. HE WAS NOT HAPPY WITH THE WAY THE HIP WAS ARTICULATING AND BEFORE THE END OF THE PROCEDURE, THE LINER AND LOCKING RING WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26650 CUS RNGLC II CONST LNR 22X32+5 PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 920540

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R