BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERAEUS MEDICAL PALACOS R AND G BONE CEMENT

    MDR report key: 5896064 · Received August 23, 2016

    Report

    Report Number
    0001822565-2016-02952
    Event Type
    Injury
    Date Received
    August 23, 2016
    Date of Event
    October 27, 2015
    Report Date
    March 29, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT: ZIMMER NEXGEN CR-FLEX FEMORAL COMPONENT CATALOG #: 00-5750-014-06 LOT #: 61757888, ZIMMER NEXGEN TIBIAL COMPONENT CATALOG #: 00-5980-047-01 LOT #: 61896565, ZIMMER NEXGEN CR ARTICULAR SURFACE CATALOG #: 00-5952-040-14 LOT #: 61983330, ZIMMER NEXGEN ALL-POLY PATELLA CATALOG #: 00-5972-066-32 LOT #: 61997971.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION. LOT NUMBER CORRECTED FROM 73774288 TO 73774286.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. EXPIRY DATE: 2015-08. (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. OPERATIVE NOTES FROM THE PRIMARY SURGERY STATE THAT THE PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY DUE TO ARTHRITIS WITH A VALGUS DEFORMITY. A FEW DEGREES OF HYPEREXTENSION AND EXCELLENT STABILITY WITH A PERFECT FLEXION AND EXTENSION GAP AND ROTATIONAL STABILITY WERE NOTED WITH TRIAL COMPONENTS. THE FINAL COMPONENTS WERE IMPLANTED WITH CEMENT AND THE KNEE WAS ¿HYPEREXTENDED¿ AND HELD UNTIL THE CEMENT HAD HARDENED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. REVIEW OF THE IMPLANTED DEVICES IDENTIFIED NO COMPATIBILITY ISSUES. OPERATIVE NOTES FROM THE REVISION SURGERY STATE THAT THE FEMORAL AND TIBIAL COMPONENTS WERE REVISED DUE TO A LOOSENING. THE PATELLAR COMPONENT WAS NOT REVISED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. PER THE NEXGEN CR-FLEX AND LPS-FLEX GENDER SOLUTIONS PACKAGE INSERT, LOOSENING IS A KNOWN RISK OF THIS PROCEDURE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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 · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT KNEE ARTHROPLASTY REVISION SURGERY DUE TO PAIN AND LOOSENING.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT KNEE ARTHROPLASTY REVISION SURGERY DUE TO PAIN AND LOOSENING. THE PATIENT WAS REVISED DUE TO FEMORAL AND TIBIAL COMPONENT LOOSENING APPROXIMATELY THREE YEARS AND EIGHT MONTHS AFTER THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549194 HERAEUS MEDICAL PALACOS R AND G BONE CEMENT KNEE PROSTHESIS JWH ZIMMER, INC. N/A 73774286

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R