BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM MOD HD SZ 50MM

    MDR report key: 3814209 · Received May 15, 2014

    Report

    Report Number
    0001825034-2014-04196
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 22, 2015
    Report Date
    January 2, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 6 STATES, "INADEQUATE RANGE OF MOTION DUE TO IMPROPER SELECTION OR POSITIONING OF COMPONENTS." NUMBER 14 STATES, "POSTOPERATIVE BONE FRACTURE AND PAIN." THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS- PART: 13-103208 NAME: TAPERLOC POR RED/LAT 15X150 LOT: 160190; PART: US157856 NAME: M2A-MAGNUM PF CUP 56ODX50ID LOT: 950210; PART: 139256 NAME: M2A-MAGNUM 42-50 TPR INSRT STD LOT: 000910. THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-06303, 0001825034-2017-06304, 0001825034-2017-06305.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS: P/N 13-103208 L/N 160190 TAPERLOC POR RED/LAT 15X150; P/N US157856 L/N 950210 M2A-MAGNUM PF CUP 56ODX50ID. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PROVIDED OP NOTES. REVIEW OF REVISION OP NOTES INDICATE THAT PATIENT UNDERWENT REVISION THA DUE TO PAIN. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO PAIN, DIFFICULTY SLEEPING, AND DIFFICULTY WALKING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. PATIENT'S LEGAL COUNSEL FURTHER REPORTED PATIENT ALLEGATIONS OF PAIN AND LOSS OF MOBILITY. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE. 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
    290988 M2A-MAGNUM MOD HD SZ 50MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 522530

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R