BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MODULAR HEAD STD NK

    MDR report key: 3966411 · Received July 30, 2014

    Report

    Report Number
    0001825034-2014-06595
    Event Type
    Injury
    Date Received
    July 30, 2014
    Report Date
    December 10, 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
    SC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS OMITTED IN ERROR ON 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: "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. THIS REPORT IS NUMBER 1 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-06595 / 06599).

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 1995 AND RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2004. PATIENT'S LEGAL COUNSEL FURTHER REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION PROCEDURE ON (B)(6) 2009 DUE TO PATIENT ALLEGATIONS OF POLYETHYLENE WEAR, DISLOCATIONS AND INSTABILITY. IT WAS FURTHER ALLEGED THAT A SECOND LEFT HIP REVISION PROCEDURE TOOK PLACE ON (B)(6) 2009 DUE TO RECURRENT DISLOCATIONS. LEGAL COUNSEL FOR PATIENT REPORTED PATIENT ALLEGATIONS OF RIGHT HIP PAIN, NUMBNESS, FEELING OF "MOVEMENT" IN HIP, DYSFUNCTION, LOSS OF RANGE OF MOTION AND DIFFICULTY WALKING. THERE HAS BEEN NO REPORTED REVISION PROCEDURE OF THE RIGHT HIP TO DATE. A REVIEW OF INVOICE HISTORY CONFIRMED THE INITIAL RIGHT HIP SURGERY DATE; HOWEVER, INVOICE HISTORY COULD NOT CONFIRM THE INITIAL LEFT HIP SURGERY. REVIEW OF INVOICE HISTORY REVEALED THAT AN ACTIVE ARTICULATION LINER AND MODULAR HEAD WERE IMPLANTED DURING THE FIRST LEFT HIP REVISION PROCEDURE ON (B)(6) 2009. INVOICE HISTORY FURTHER CONFIRMED THAT THE ACTIVE ARTICULATION LINER AND MODULAR HEAD WERE REMOVED AND REPLACED WITH A CONSTRAINED SYSTEM DURING THE SECOND LEFT REVISION PROCEDURE ON (B)(6) 2009. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443203 M2A 38MM MODULAR HEAD STD NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 568260

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R