BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM ONE PIECE CUP SZ 50MM

    MDR report key: 5205630 · Received November 5, 2015

    Report

    Report Number
    0001825034-2015-04522
    Event Type
    Injury
    Date Received
    November 5, 2015
    Date of Event
    December 6, 2012
    Report Date
    December 15, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. ROOT CAUSE OF THE EVENT WAS MOST LIKELY ATTRIBUTED TO SURGICAL TECHNIQUE OR EXTERNAL FACTORS. PRODUCT NOT RETURNED TO ZIMMER BIOMET FACILITY. ZIMMER BIOMET EMPLOYEES EVALUATED PRODUCT AT THE SOUTH HAMPTON FACILITY. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 11 STATES, "WEAR AND/OR DEFORMATION OF ARTICULATING SURFACES." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES." 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." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-042901 / 042902).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION. EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCE. VISUAL EXAMINATION OF THE COMPONENTS HAVE INDICATED THE PRESENCE OF A WEAR PATCH ADJACENT TO THE RIM OF THE CUP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO ADVERSE REACTION TO METAL DEBRIS (ARMD). OPERATIVE REPORT NOTED A THICKENED CAPSULE CONTAINING CLEAR FLUID LOCATED IN THE TROCHANTERIC BURSA AND METALLOSIS OVER THE TRUNNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733999 M2A 38MM ONE PIECE CUP SZ 50MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 438270

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R