BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOMXL 32MM +3 HW LNR SZ 22

    MDR report key: 5260482 · Received December 2, 2015

    Report

    Report Number
    0001825034-2015-04816
    Event Type
    Injury
    Date Received
    December 2, 2015
    Date of Event
    November 9, 2015
    Report Date
    February 26, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK062997
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. REVIEW OF THE DEVICE CONFIRMED THE REPORTED CONDITION. WEAR OF THE RETURNED PRODUCT WAS NOTED; HOWEVER, A CONCLUSIVE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2015 DUE TO PAIN AND OSTEOLYSIS IN THE PROXIMAL FEMUR. AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED AND ALLOGRAFT BONE WAS GRAFTED ONTO THE PATIENT'S PROXIMAL FEMUR. THE MODULAR HEAD AND POLYETHYLENE LINER WERE REMOVED AND REPLACED. IT WAS NOTED DURING THE REVISION PROCEDURE THAT THE LINER WAS DISCOLORED, HOWEVER IT WAS NOT FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790161 ARCOMXL 32MM +3 HW LNR SZ 22 PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 274110

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R