BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, KNEE

    MDR report key: 5261675 · Received December 2, 2015

    Report

    Report Number
    0001825034-2015-04831
    Event Type
    Injury
    Date Received
    December 2, 2015
    Report Date
    November 10, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK080528
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    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 15 STATES, "INTRAOPERATIVE OR POSTOPERATIVE BONE FRACTURE AND/OR POSTOPERATIVE PAIN." PATIENT IS BILATERAL AND IT IS UNKNOWN WHICH SIDE THE PATIENT IS ALLEGING PAIN; THEREFORE THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: BRAND NAME - E1 VNGD CRL TIB BRG 79/83X12. CATEGORY NUMBER - EP-183562. LOT NUMBER - 973230. EXPIRATION DATE - AUG 31, 2017. MANUFACTURE DATE ¿ AUG 29, 2012. OR THE PART/LOT INFORMATION COULD BE: BRAND NAME - E1 VNGD CRL TIB BRG 79/83X10. CATEGORY NUMBER - EP-183560. LOT NUMBER - 398800. EXPIRATION DATE - JUN 30, 2015. MANUFACTURE DATE ¿ JUN 4, 2010. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT BILATERAL KNEE ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT ALLEGED PAIN. NO REVISION PROCEDURE HAS OCCURRED. NO FURTHER INFORMATION HAS BEEN PROVIDED. 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
    791289 PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention