BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW 6.5X40MM

    MDR report key: 7517346 · Received May 15, 2018

    Report

    Report Number
    0001825034-2018-03382
    Event Type
    Injury
    Date Received
    May 15, 2018
    Date of Event
    August 18, 2004
    Report Date
    April 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: BIOMET ARCOM POROUS 4 SPIKE PATELLA, CATALOG #: 11-150852 LOT #: 141410, BIOMET POROUS TIBIAL TRAY, CATALOG #: 141263 LOT #: 139040, MAXIM POROUS FEMORAL, CATALOG #: 140052 LOT #: 230920. REPORTED EVENT WAS CONFIRMED BY REVISION OPERATIVE NOTES RECEIVED. REVISION OPERATIVE NOTES IDENTIFIED PATIENT WAS REVISED DUE TO FAILED KNEE ARTHROPLASTY. IT WAS IDENTIFIED PATIENT WAS REVISED DUE TO PROGRESSIVE LOOSENING. RADIOGRAPHICALLY, BONE SCAN AND CLINICALLY SUGGESTED LOOSE IMPLANT. THERE WERE NO ALLEGATIONS ON THE SCREW COMING APART FROM THE MEDIAL RECORDS PROVIDED. RADIOLOGY REPORTS WERE PROVIDED AND IDENTIFIED PROSTHESIS TO BE IN SATISFACTORY POSITION. THE AP VIEW IS OBLIQUE BUT PATELLA APPEARED ROTATED LATERALLY. A RIBBON LIKE SURGICAL ARTIFACT IS SEEN ANTERIOR TO THE TIBIA. REVIEW OF DEVICE HISTORY RECORDS (DHR) WITH NO DEVIATIONS OR ANOMALIES IDENTIFIED THAT AFFECT THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD ALTER OR CHANGE ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED. 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). MEDICAL DEVICES: 103535, RINGLOC TI LOW PROFILE SCREW 6.5X40MM, 291200; 103532, TI LOW PROFILE SCREW 6.5X25MM, 120650; 103535, TI LOW PROFILE SCREW 6.5X40MM, 291200; CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 03383.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO THE SCREWS COMING APART ACCOMPANIED BY PAIN AND INABILITY TO BEND THE KNEE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359250 TI LOW PROFILE SCREW 6.5X40MM PROSTHESIS, KNEE KWA ZIMMER BIOMET, INC. N/A 291200

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R