BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MMX58MM CUP

    MDR report key: 3103001 · Received May 9, 2013

    Report

    Report Number
    0001825034-2013-01319
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    September 23, 2004
    Report Date
    October 6, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, NUMBER 14 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01319 / 01320).

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY UNDERWENT A REVISION TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. A SUBSEQUENT REVISION OF THE CUP WAS PERFORMED (B)(6) 2004 DUE TO PAIN AND A TROCHANTERIC FRAGMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2003. A SUBSEQUENT REVISION OF THE CUP WAS PERFORMED (B)(6) 2004 DUE TO PAIN AND A TROCHANTERIC FRAGMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA REGARDING PATIENTS ENROLLED IN A CLINICAL STUDY. IT WAS REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2002. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2003 DUE TO AN UNKNOWN REASON. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. PATIENT UNDERWENT FURTHER REVISION PROCEDURE ON (B)(6) 2004 DUE TO A LOOSE ACETABULAR CUP, PAIN, AND A TROCHANTERIC FRAGMENT. THE MODULAR HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. ADDITIONAL INFORMATION REVEALED PATIENT DATE OF BIRTH, AND REVIEW OF INVOICE HISTORY INDICATE DATE OF SECOND REVISION PROCEDURE OCCURRED ON (B)(6) 2004. HOSPITAL RECORDS INDICATE DATE OF REVISION PROCEDURE OCCURRED ON (B)(6) 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203218 M2A 38MMX58MM CUP PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 607810

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R