BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD +3MM NK

    MDR report key: 3221190 · Received July 11, 2013

    Report

    Report Number
    0001825034-2013-02632
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 11, 2013
    Report Date
    January 12, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE FOUND NO EVIDENCE OF PRODUCT NON-CONFORMANCES. THE HEAD AND CUP APPEARED TO SHOW EVIDENCE OF SUBLUXATION OF THE JOINT AND SCRATCHING OF THE BEARING SURFACES.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION THAT WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: ¿ELEVATED METAL ION LEVELS HAVE BEEN REPORTED WITH METAL-ON-METAL ARTICULATING SURFACES.¿ AND ¿MATERIAL SENSITIVITY REACTIONS.¿ THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-02632/-02633/-06129/-06130).

    Additional Manufacturer Narrative · 1

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

    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. 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." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THIS EVENT (REFERENCE 1825034-2013-02632 / 02633).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY (B)(6) 2004. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 ALLEGEDLY DUE TO PAIN AND PSEUDOTUMORS. THE CUP AND HEAD WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT¿S REVISION OPERATIVE REPORT INDICATES THE PRESENCE OF PAIN, FLUID AND PSEUDOTUMOR-LIKE TISSUE. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. MEDICAL RECORDS FURTHER NOTE THAT TOTAL HIP ARTHROPLASTY WAS PERFORMED ON BOTH THE RIGHT AND LEFT HIPS ON (B)(6) 2004. THERE HAS BEEN NO REVISION REPORTED FOR THE RIGHT HIP.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHOPLASTY (B)(6) 2004. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013, ALLEGEDLY DUE TO PAIN AND PSEUDOTUMORS. THE CUP AND HEAD WERE REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY (B)(6) 2004. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 ALLEGEDLY DUE TO PAIN AND PSEUDOTUMORS. THE CUP AND HEAD WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN THE PATIENT'S REVISION OPERATIVE (OP) REPORT INDICATES THE PRESENCE OF PAIN, FLUID AND PSEUDOTUMOR-LIKE TISSUE. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. MEDICAL RECORDS FURTHER NOTE THAT TOTAL HIP ARTHROPLASTY WAS PERFORMED ON BOTH THE RIGHT AND LEFT HIPS ON (B)(6) 2004. ADDITIONAL INFORMATION RECEIVED IN PATIENT OP NOTES REPORTS PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE ON (B)(6) 2014 DUE TO PAIN AND DISCOMFORT. RIGHT REVISION OP REPORT NOTES THE PRESENCE OF SCAR TISSUE, ADHESIONS, YELLOWISH FLUID, AND PSEUDOTUMOR-TYPE CAPSULE. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320116 M2A 38MM MOD HD +3MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 609930

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R