BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOMXL 36MM RINGLOC LINER HW SZ24

    MDR report key: 3961970 · Received July 28, 2014

    Report

    Report Number
    0001825034-2014-06478
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    March 11, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK051411
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS." AND "IT HAS BEEN REPORTED THAT WEAR DEBRIS MAY INITIATE A CELLULAR RESPONSE RESULTING IN OSTEOLYSIS OR OSTEOLYSIS MAY BE A RESULT OF LOOSENING OF THE IMPLANT." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-002046 & 006478).

    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

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA REGARDING PATIENTS ENROLLED IN (B)(6). IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. DURING POST OPERATIVE MONITORING AND TESTING, A MALPOSITIONED ACETABULAR CUP AND FEMORAL OSTEOLYSIS WERE NOTED. PATIENT FURTHER REPORTED PAIN, KNEE/ANKLE ISSUES ON THE IPSILATERAL SIDE, STIFFNESS, LEG LENGTH DISCREPANCY AND CLICKING. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE..

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA REGARDING PATIENTS ENROLLED IN A 522 CLINICAL STUDY. IT WAS REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. DURING POST OPERATIVE MONITORING AND TESTING, MALPOSITIONED ACETABULAR CUP AND FEMORAL OSTEOLYSIS WERE NOTED. THESE FINDINGS WERE FOUND DUE TO FOLLOW UP TESTING, THERE WERE NO SYMPTOMS REPORTED BY THE PATIENT. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437694 ARCOMXL 36MM RINGLOC LINER HW SZ24 PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 477430

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R