BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-38 CUP NON FLARED SZ 58MM

    MDR report key: 3137465 · Received May 30, 2013

    Report

    Report Number
    0001825034-2013-01715
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THAT AFTER A REVIEW OF THE INVOICE HISTORY, IT WAS DISCOVERED THAT TWO ACETABULAR CUPS WERE INVOICED DURING THE INITIAL PROCEDURE; HOWEVER, ONLY ONE WAS IMPLANTED. THE CUP ASSOCIATED WITH THIS MANUFACTURER REPORT NUMBER WAS NEVER IMPLANTED. THE CUP THAT WAS IMPLANTED DURING THE INITIAL PROCEDURE WAS REPORTED ON MANUFACTURER REPORT NUMBER 1825034-2013-01710.

    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. AS TWO CUPS WERE LISTED ON THE INVOICE FROM THE PROCEDURE ON (B)(6) 2009, IT IS UNKNOWN WHICH ONE WAS IMPLANTED ON THAT DATE. IT IS ONE OF THE FOLLOWING TWO: 15-103688 LOT 742230, 15-106058 LOT 081850. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, "EARLY OR LATE POSTOPERATIVE, INFECTION, AND ALLERGIC REACTION." AND UNDER WARNINGS IT STATES, "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. MALALIGNMENT OF THE COMPONENTS OR INACCURATE IMPLANTATION CAN LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE IMPLANT OR PROCEDURE." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 8 OF 8 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01708 / 01715).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT UNKNOWN TOTAL HIP ARTHROPLASTY ON UNKNOWN DATE. PATIENT WAS SUBSEQUENTLY REVISED TO BIOMET PRODUCT FOR UNKNOWN REASON ON (B)(6) 2009. A DEBRIDEMENT WAS PERFORMED (B)(6) 2010 DUE TO INFECTION. A CLOSED REDUCTION WAS PERFORMED (B)(6) 2010 AND A FURTHER CLOSED REDUCTION (B)(6) 2013 DUE TO DISLOCATION. A SUBSEQUENT REVISION WAS PERFORMED (B)(4) 2013 ,DUE TO DISLOCATION AND VERTICAL AND ANTEVERTED CUP. THE CUP, LINER AND HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238330 M2A-38 CUP NON FLARED SZ 58MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 081850

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R