BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPS LG SHT SPDL W PINS 600LBF

    MDR report key: 9799341 · Received March 6, 2020

    Report

    Report Number
    0001825034-2020-01021
    Event Type
    Injury
    Date Received
    March 6, 2020
    Date of Event
    January 28, 2020
    Report Date
    June 25, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K101475
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 0

    FROM ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED THAT THE COMPRESS LOST COMPRESSION DUE TO POOR BONE QUALITY. THE SPINDLE AND ANCHOR PLUG PROSTHESIS EXERT THE UPWARD FORCE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CPS SHORT ANCHOR PLUG 18MM P # 178560 L# 317690, CPS TRANSVERSE PIN 6PK 44MM P# 178530 L# 871590, CPS NUT CO-CR-MO ALLOY P# 178512 L# 025940, CPS TRANSVERSE PIN 6PK 56MM P# 178533 L# 787380, CPS/OSS 5CM TPR ADAPT W/OSS SC P# 178711 L# 365780, OSS 4CM DIAPHYSEAL SEGMENT P# 150482 L# 983620 CPS X-LONG PIN 6PK 68MM P# 178572 L# 045410, CPS TRANSVERSE PIN 6PK 60MM P# 178534 L# 599280, CPS CENTERING SLEEVE 21MM P# 178543 L# 599280. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2020-01014. 0001825034-2020-01015. 0001825034-2020-01016. 0001825034-2020-01017. 0001825034-2020-01018. 0001825034-2020-01019. 0001825034-2020-01023. 0001825034-2020-01025. 0001825034-2020-01027.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO FAILURE OF THE COMPRESS SPINDLE AND POOR BONE QUALITY. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261888 CPS LG SHT SPDL W PINS 600LBF PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 662330

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R