BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MODULAR HEAD -6MM NK

    MDR report key: 4792247 · Received May 22, 2015

    Report

    Report Number
    0001825034-2015-02188
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    April 29, 2015
    Report Date
    October 19, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." NUMBER 15 STATES, "ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL ON METAL ARTICULATING SURFACES." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2015-02187).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: M2A 38MMX52MM CUP P/NRD118852 L/N 175800; MLRY-HD LAT POR FMRL 10X155MM P/N 11-104210 L/N 000190. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PROVIDED OP NOTES AND X-RAYS. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE REVISION OP NOTES INDICATE: THE PATIENT WAS REVISED DUE TO ELEVATED METAL ION LEVELS. DURING THE PROCEDURE, EXCESSIVE EFFUSION WAS FOUND AROUND THE HIP, GRAYISH COLORED REACTIVE TISSUE WAS ALSO NOTED. THE TISSUE WAS DEBRIDED. THE SURGEON FELT FINAL IMPLANT WAS APPROPRIATE, STABLE IMPLANT THROUGH RANGE OF MOTION. REVIEW OF THE RADIOGRAPH REPORT FOR IMAGE SHOW ACETABULAR CUP ANGLE OF INCLINATION APPEARED STEEP, GREATER THAN 45 DEGREES, ALTHOUGH CANNOT BE DIRECTLY MEASURED FROM THE IMAGE DUE TO EXCLUSION OF BONY LANDMARKS USED FOR MAKING THIS MEASUREMENT. IT WAS ALSO NOTED THERE IS A SMALL DEFECT OF THE METAL RIM OF THE ACETABULAR CUP, WHICH PROJECTS JUST LATERAL TO THE FEMORAL NECK COMPONENT. THE FEMORAL HEAD APPEARED TO BE LOCATED AND WELL CENTERED WITHIN THE ACETABULAR CUP. FEMORAL COMPONENT FIT AND ALIGNMENT APPEARED STANDARD. GENERAL BONE QUALITY APPEARS GROSSLY NORMAL. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, OPERATIVE REPORT NOTED PATIENT WAS REVISED ON (B)(6) 2015 DUE TO PAIN AND ELEVATED METAL ION LEVELS. OPERATIVE REPORT FURTHER NOTED FLUID, EFFUSION AND GRAYISH-COLORED REACTIVE TISSUE DURING THE REVISION PROCEDURE. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336420 M2A 38MM MODULAR HEAD -6MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 204500

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R