BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS ANTIBIOTIC BONE CEMENT

    MDR report key: 7372750 · Received March 27, 2018

    Report

    Report Number
    0001822565-2018-01794
    Event Type
    Injury
    Date Received
    March 27, 2018
    Report Date
    June 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    PK150119
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: PALACOS ANTIBIOTIC BONE CEMENT, CATALOG #: 00111314001, LOT #: 83314477. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2017-06733, 0001822565-2018-01794. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. CONCOMITANT MEDICAL DEVICES ¿ VANGARD POSTERIOR STABILIZED OPEN INTERLOK FEMORAL COMPONENT RIGHT 65MM CATALOG #: 183108 LOT #: J3735940, BIOMET FIXED CRUCIATE TIBIAL PLATE 75MM CATALOG #: 141234 LOT #: J3790936, VANGUARD POSTERIOR STABILIZED E1 ANTIOXIDANT INFUSED TIBIAL BEARING 12MM CATALOG #: EP-183642 LOT #: 113380, VANGUARD SERIES A STANDARD PATELLA CATALOG #: 184764 LOT #: 173220, PALACOS ANTIBIOTIC BONE CEMENT, CATALOG #: 00111314001, LOT #: 83314477. THE PRODUCT WAS REVIEWED THROUGH MANUFACTURING REVIEW AND THE REPORTED EVENT WAS CONFIRMED THROUGH RADIOGRAPHIC INSPECTION. REVIEW OF THE PRIMARY SURGERY OP-NOTES IDENTIFIED NO DEVIATIONS OR COMPLICATIONS DURING THE PROCEDURE. REVIEW OF THE PHYSICAL THERAPY NOTES INDICATE THAT THE PATIENT HAD A GRADUAL INCREASE IN PAIN. DURING THE SESSIONS, THE PATIENT'S TOLERANCE TO THERAPY WAS GOOD, AND RANGE OF MOTION OF 0-120 DEGREES WAS ACHIEVED, HOWEVER, THE PATIENT EXPERIENCES PAIN 2 HRS AFTER THE SESSION AND REPORTS WEAKNESS. AS THE CAUSE OF THE PAIN WAS UNKNOWN, PHYSICAL THERAPY WAS STOPPED UNTIL FURTHER FOLLOW-UP WITH THE SURGEON. ALSO, A MILD EFFUSION WAS NOTED IN PATIENT'S KNEE. A RADIOGRAPHIC REVIEW NOTED THE PRESENCE OF MILD RADIOLUCENCY AT THE BONE CEMENT INTERFACE ALONG THE MEDIAL TIBIAL PLATEAU IN ADDITION TO THE ANTERIOR AND POSTERIOR TIBIAL PLATEAU WHICH COULD SUGGEST EARLY LOOSENING. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. THE SUPPLIER IDENTIFIED THAT THE INADEQUATE PERFORMANCE CHARACTERISTICS OF THE BONE CEMENT VERY LIKELY TO BE A RESULT OF INCORRECT/INADEQUATE PREPARATION, HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE PROVIDED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2017-06733, 0001822565-2018-01794, 0001825034-2017-08012, 0001825034-2017-08013, 0001825034-2017-08014, 0001825034-2017-08015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN, STIFFNESS, SWELLING AND DIFFICULTY AMBULATING. RADIOGRAPHS SHOW RADIOLUCENCY AT THE CEMENTED INTERFACES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216861 PALACOS ANTIBIOTIC BONE CEMENT BONE CEMENT LOD ZIMMER BIOMET, INC. N/A 83724480

    Patients

    Seq Age Sex Outcome Treatment
    1 Other