BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28MM MOD HD CERAMIC +6MM NK

    MDR report key: 4352757 · Received December 22, 2014

    Report

    Report Number
    0001825034-2014-09199
    Event Type
    Injury
    Date Received
    December 22, 2014
    Date of Event
    November 11, 2013
    Report Date
    March 30, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK925345
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 ANOMALY OR DEVIATION. IT CANNOT BE DETERMINED WHICH HIP THIS PART NUMBER WAS IMPLANTED IN. THEREFORE, THE EXACT DATES COULD NOT BE PROVIDED FOR THE FOLLOWING SECTIONS: DATE OF EVENT - (B)(6) 2013 OR (B)(6) 2014. DATE EXPLANTED - (B)(6) 2013 OR (B)(6) 2014. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-09156 & 09199).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 163134, LOT NUMBER - 001720, EXPIRATION DATE - JUN 30, 2009, IMPLANT DATE - (B)(6) 1999, MANUFACTURE DATE ¿ JUN 1, 1999; OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 163132, LOT NUMBER - 216110, EXPIRATION DATE - JAN 31, 2009, IMPLANT DATE- (B)(6) 1999, MANUFACTURE DATE ¿ JAN 8, 1999.

    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 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." THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: LOT NUMBER - 001720, EXPIRATION DATE - JUN 30, 2009, IMPLANT DATE - (B)(6) 1999, MANUFACTURE DATE ¿ JUN 1, 1999; OR THE PART/LOT INFORMATION COULD BE: LOT NUMBER - 216110, EXPIRATION DATE - JAN 31, 2009, IMPLANT DATE- (B)(6) 1999, MANUFACTURE DATE ¿ JAN 8, 1999.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY ON (B)(6) 1999. IT IS NOT KNOWN WHICH DATE IS FOR THE LEFT HIP OR WHICH IS FOR THE RIGHT HIP. SUBSEQUENTLY, A RIGHT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 FOR AN UNKNOWN REASON. THE ACETABULAR LINER AND MODULAR HEAD WERE REMOVED AND REPLACED. RADIOGRAPHS WERE RECEIVED OF THE PATIENT'S LEFT HIP WITH A REQUEST FOR PRODUCT IDENTIFICATION. A SUBSEQUENT REVIEW OF INVOICE HISTORY FOUND THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2014 DUE TO AN UNKNOWN REASON; PRESUMABLY ON THE LEFT HIP. SONS; THE ACETABULAR LINER AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY ON (B)(6) 1999 AND (B)(6) 1999. IT IS UNKNOWN WHICH DATE IS FOR THE LEFT HIP OR WHICH IS FOR THE RIGHT HIP. SUBSEQUENTLY, A RIGHT HIP REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 DUE TO AN UNKNOWN REASON. THE ACETABULAR LINER AND MODULAR HEAD WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED FROM OPERATIVE REPORT NOTED PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE ON (B)(6) 2014 DUE TO PAIN AND POLY WEAR. THE ACETABULAR LINER AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840383 28MM MOD HD CERAMIC +6MM NK PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 001720

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R