BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM RNGLC TRI-POLAR LNR SZ26 - TRI-POLAR SYSTEM

    MDR report key: 4135085 · Received October 2, 2014

    Report

    Report Number
    0001825034-2014-07946
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    September 9, 2014
    Report Date
    October 2, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWY
    PMA / PMN Number
    PK991990
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 AND TO CORRECT INFORMATION THAT WAS UNKNOWN AND REPORTED IN ERROR ON THE INITIAL REPORT. CORRECT PRODUCT CODE IS KWY. CURRENT INFORMATION IS STILL 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 ¿POSTOPERATIVE BONE FRACTURE AND PAIN.¿ THIS REPORT IS NUMBER 1 OF 4 MDR'S FILED FOR THE SAME PATIENT WHO HAD MULTIPLE REVISIONS SPANNING 18 YEARS (REFERENCE 1825034-2014- 07946 / 08143/ 08144 / 08144).

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. BRAND NAME - UNKNOWN. PRODUCT IDENTIFICATION & EXPIRATION DATE - UNKNOWN. IMPLANT DATE -- UNKNOWN. PMA/510(K) NUMBER. MANUFACTURE DATE ¿ UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2014 DUE TO A FEMORAL FRACTURE SUSTAINED FROM A PATIENT FALL DUE TO UNKNOWN REASONS. A COMPETITOR STEM AND HEAD WERE REMOVED AND REPLACED BY A COMPETITOR STEM AND HEAD. THE RINGLOC LINER WAS ALSO REMOVED AND REPLACED BY A NEW LINER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS ON (B)(6) 1997, (B)(6) 1998, AND (B)(6) 2000. THE PATIENT WAS AGAIN REVISED ON (B)(6) 2014 DUE TO A FEMORAL FRACTURE SUSTAINED FROM A PATIENT FALL. A COMPETITOR STEM AND HEAD WERE REMOVED AND REPLACED BY A COMPETITOR STEM AND HEAD. THE RINGLOC LINER WAS ALSO REMOVED AND REPLACED BY A NEW LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615667 ARCOM RNGLC TRI-POLAR LNR SZ26 - TRI-POLAR SYSTEM PROSTHESIS, HIP KWY BIOMET ORTHOPEDICS N/A 811660

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R