BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 4485472 · Received February 4, 2015

    Report

    Report Number
    0001825034-2015-00400
    Event Type
    Injury
    Date Received
    February 4, 2015
    Report Date
    January 16, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 RELATED TO THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED DUE TO THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 180550, LOT NUMBER - 521430, EXPIRATION DATE ¿ JUNE 30, 2024 , PMA/510(K) NUMBER - K080642, MANUFACTURE DATE ¿ JUNE 12, 2014. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER -180552, LOT NUMBER - 309170, EXPIRATION DATE - NOVEMBER 30, 2024, PMA/510(K) NUMBER - K080642, MANUFACTURE DATE ¿ NOVEMBER 13, 2014. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER -180560, LOT NUMBER - 438920, EXPIRATION DATE - NOVEMBER 30, 2023, PMA/510(K) NUMBER - K080642, MANUFACTURE DATE ¿ DECEMBER 3, 2013. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER -180563, LOT NUMBER - 027190, EXPIRATION DATE - OCTOBER 31, 2023, PMA/510(K) NUMBER - K080642, MANUFACTURE DATE ¿ OCTOBER 27, 2014. OR THE PART/LOT INFORMATION COULD BE: CATALOG NUMBER - 115395, LOT NUMBER - 402790, EXPIRATION DATE - AUGUST 31, 2024, PMA/510(K) NUMBER ¿ K113121, MANUFACTURE DATE ¿ AUGUST 22, 2014. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A COMPREHENSIVE REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2014. REVIEW OF RADIOGRAPHS ONE MONTH POSTOPERATIVE REVEALED THAT ONE OF THE SCREWS HAS STRIPPED. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79582 UNKNOWN SCREW PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention