BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS R 1X40 SINGLE

    MDR report key: 13827181 · Received March 19, 2022

    Report

    Report Number
    0001822565-2022-00787
    Event Type
    Injury
    Date Received
    March 19, 2022
    Date of Event
    March 10, 2017
    Report Date
    April 12, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    K030902
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 96-0082 DEPUY FEMORAL SIZE 3 343528, 96-2132 DEPUY TIBIAL INSERT 7810413, 86-7430 DEPUY 115MM STEM 370053, 96-0781 DEPUY FEMORAL ADAPTER 454340, 96-0784 DEPUY FEMORAL ADAPTER BOLT 446662, 96-0862 DEPUY SIGMA DISTAL AUGMENT 449927, AND 96-0866 DEPUY SIGMA POSTERIOR AUG 418405. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 · 0

    (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. AS ZIMMER BIOMET DOES NOT HOLD INVESTIGATION RESPONSIBILITY FOR THE REPORTED PRODUCT A COMPLAINT HISTORY SEARCH WILL NOT BE PERFORMED. THE FOLLOWING SUMMARY WAS PROVIDED BY AN ALLIANCE PARTNER: QUALITY DEVIATIONS: NONE. CHANGE NOTIFICATIONS: NONE. IT IS CURRENTLY UNCLEAR WHY A LOOSENING AT THE CEMENT ¿ IMPLANT INTERFACE OCCURRED AFTER 3 YEARS. IN THE SURGERY REPORT NO INFORMATION ABOUT THE CEMENTING TECHNIQUE AND A POSSIBLE CONTAMINATION OF THE IMPLANTS IS PROVIDED. SINCE THE CEMENT ¿ BONE INTERFACE REMAINED INTACT A MALFUNCTION OF THE BONE CEMENT CAN ALMOST BE EXCLUDED. IT IS LIKELY THAT A USER ERROR OCCURRED DURING CEMENTING OF THE IMPLANTS. SINCE THE SURGERY REPORT DOES NOT CONTAIN ANY INFORMATION ABOUT THE CEMENTING TECHNIQUE AND POSSIBLE CONTAMINATION OF THE IMPLANTS A DEFINITE ROOT CAUSE FOR THE EVENT CANNOT BE DETERMINED. NEVERTHELESS, AS THE BONE CEMENT / BONE INTERFACE REMAINED INTACT A MALFUNCTION OF THE CEMENT CANAL MOST BE EXCLUDED. IT IS LIKELY THAT A USER ERROR OCCURRED DURING CEMENTATION OF THE IMPLANTS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION OF COMPETITOR IMPLANTS USING PALACOS CEMENT WAS PERFORMED. THE PATIENT WAS REVISED THREE (3) YEARS LATER DUE TO PAINFUL LOOSENING. DURING THE REVISION, IT WAS NOTED THAT THE TIBIA WAS LOOSE AT IMPLANT CEMENT INTERFACE BUT THE CEMENT BONE INTERFACE WAS INTACT. THE FEMUR WAS LOOSE AT CEMENT BONE INTERFACE. THE UNKNOWN PATELLA REMAINED INTACT, ALL OTHER COMPONENTS WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2187141 PALACOS R 1X40 SINGLE CEMENT, FIXATION LOD ZIMMER BIOMET, INC. N/A 76164320

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10.