BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM PF CUP 56ODX50ID

    MDR report key: 2850456 · Received November 29, 2012

    Report

    Report Number
    0001825034-2012-02502
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THE REASON FOR THE REVISION PROCEDURE, WHICH 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, NUMBER 1 STATES, "MATERIAL SENSITIVITY REACTIONS." NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-02502 & 1825034-2013-00129/00130).

    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 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS MAY OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY."

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION - THIS EVENT WAS ORIGINALLY REPORTED AS ACETABULAR CUP LOOSENING LEADING TO A REVISION PROCEDURE. ADDITIONAL INFORMATION RECEIVED FROM PATIENT'S LEGAL COUNSEL ALLEGES FURTHER ISSUES AND THE EVENT DESCRIPTION WAS UPDATED TO REFLECT THE NEW INFORMATION. BASED ON THE NEW INFORMATION RECEIVED, ADDITIONAL MEDWATCHES ARE BEING SUBMITTED ON THE OTHER COMPONENTS REMOVED DURING THE REVISION ON (B)(6) 2012. PLEASE REFERENCE MEDWATCH NUMBERS 1825034-2013-00129 & 1825034-2013-00130 AS THEY ARE REPORTING THE SAME PATIENT/EVENT.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT THE PATIENT UNDERWENT A M2A HIP ARTHOPLASTY ON (B)(6) 2006 AND THAT A SUBSEQUENT REVISION PROCEDURE OCCURRED ON (B)(6), 2012. PATIENT'S LEGAL COUNSEL FURTHER ALLEGES PAIN, INFLAMMATION, COMPLICATIONS WITH HIP POPPING, DISLOCATION, AND DIFFICULTY WITH MOBILITY. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH SURGERY DATES AND THAT THE ACETABULAR CUP, MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2012 WAS DUE TO METALLOSIS, PAIN, LACK OF MOBILITY, CYSTS AND BONE LOSS. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP, TAPER ADAPTER AND MODULAR HEAD WERE REMOVED AND REPLACED. THIS REPORTS IS BASED ON ALLEGATIONS SET FORTH IN THE PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED (B)(6) 2012 ALLEGEDLY DUE TO CUP LOOSENING. THE CUP, HEAD AND LINER WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT THE PATIENT UNDERWENT A M2A HIP ARTHROPLASTY ON (B)(6) 2006 AND THAT A SUBSEQUENT REVISION PROCEDURE OCCURRED ON (B)(6) 2012. PATIENT'S LEGAL COUNSEL ALLEGES PAIN, INFLAMMATION, COMPLICATIONS WITH HIP POPPING, DISLOCATION, AND DIFFICULTY WITH MOBILITY. A REVIEW OF INVOICE HISTORY CONFIRMED BOTH SURGERY DATES AND THAT THE ACETABULAR CUP, MODULAR HEAD AND TAPER INSERT WERE REMOVED AND REPLACED. THIS REPORTS IS BASED ON ALLEGATIONS SET FORTH IN THE PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A-MAGNUM PF CUP 56ODX50ID PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 056030

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R