BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD -3MM NK

    MDR report key: 4093695 · Received September 16, 2014

    Report

    Report Number
    0001825034-2014-07740
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    April 29, 2014
    Report Date
    October 15, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN.¿

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED PRODUCT SHOWS RIM DEFORMATION CONSISTENT WITH IMPINGEMENT BETWEEN THE POLYETHYLENE AND A PORTION OF THE HEAD OR STEM, DEPENDING ON WHETHER THE IMPINGEMENT OCCURRED BEFORE OR AFTER THE DISASSOCIATION. THE RIM FRACTURE ON THE OPPOSITE SIDE OF THE IMPINGEMENT SHOWS EVIDENCE OF THINNING OF THE POLYETHYLENE. IN ADDITION, THERE WAS A FRACTURE NOTED THAT LIKELY PROPAGATED DOWN FROM THE RIM. IT COULD NOT BE DETERMINED IF THE FRACTURE WAS CAUSED BY THE REPORTED TRAUMA OR OCCURRED AS A SECONDARY FRACTURE AFTER THE TRAUMA OR DISASSOCIATION. THERE IS NO INDICATION, WITH THE INFORMATION AVAILABLE, THAT THERE IS ANY NON-CONFORMANCE IN THE PRODUCTS AS MANUFACTURED. THE LIKELY CAUSE IS PATIENT WEIGHT AND THE REPORTED FALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6), 2005 AND LEFT TOTAL HIP ARTHROPLASTY ON (B)(6), 2006. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY ON THE LEFT SIDE ON (B)(6), 2014 DUE TO PAIN. SUBSEQUENTLY, PATIENT HAD THE LEFT SIDE REVISED ON (B)(6), 2014 DUE TO PATIENT FALL CAUSING A FRACTURE AND DISSOCIATION. SURGEON STATED THAT HE DID NOT BELIEVE THIS WAS DUE TO PRODUCT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573380 M2A 38MM MOD HD -3MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 574780

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R