BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS NON-ANTIBIOTIC BONE CEMENT

    MDR report key: 7189168 · Received January 15, 2018

    Report

    Report Number
    0001822565-2018-00271
    Event Type
    Injury
    Date Received
    January 15, 2018
    Date of Event
    December 20, 2017
    Report Date
    February 19, 2019
    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
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. EVALUATION OF THE RETURNED TIBIAL COMPONENT IDENTIFIED SCRATCHES ANTERIORLY NEAR THE CUT OUT FOR ASSEMBLY WITH THE ARTICULAR SURFACE INSERTER. THE TIBIAL COMPONENT ALSO HAD BONE CEMENT ON THE DISTAL SURFACE. THE COMPONENT WIDTH WAS MEASURED AND FOUND CONFORMING TO PRINT SPECIFICATIONS. THE ARTICULAR SURFACE WAS ALSO RETURNED AND SHOWED WEAR ON THE MATING CONDYLAR SURFACES. ONE PAGE FROM THE PRIMARY OPERATIVE NOTES WAS PROVIDED INDICATING THE PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS AND PSORIATIC ARTHRITIS. THE DESCRIPTION OF THE PROCEDURE WAS NOT PROVIDED. HCP REVIEW OF THE RETURNED X-RAYS IDENTIFIED RADIOLUCENCY ALONG THE BONE CEMENT INTERFACE DIFFUSELY AT THE TIBIAL COMPONENT AND FOCAL LUCENCY SEEN AT THE TIP OF THE TIBIAL STEM AT THE CEMENT AND HARDWARE INTERFACE. OVERALL IMPLANT SIZE AND ALIGNMENT WERE NOTED TO BE APPROPRIATE. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 - 2018 - 00272 - 1, 0001822565 - 2018 - 00273 - 1.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: PERSONA NATURAL TIBIA CEMENTED, CATALOG # 42532006702, LOT # 63506421; PALACOS NON-ANTIBIOTIC BONE CEMENT ,CATALOG # 00111214001, LOT # 8233442; VE PS ARTICULAR SURFACE, CATALOG # 42522400510, LOT # 63493374. THIS BONE CEMENT IS MANUFACTURED AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS. PRODUCT IS NOT RETURNED TO ZIMMER BIOMET. 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: 0001822565-2018-00272, 0001822565-2018-00273.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL RIGHT KNEE REPLACEMENT. AFTER A FEW MONTHS, THE PATIENT WAS EXPERIENCING PAIN. LAB WORK AND X-RAYS INDICATED ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. THE SURGEON PERFORMED A REVISION SURGERY DUE TO LOOSENING OF TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35110 PALACOS NON-ANTIBIOTIC BONE CEMENT BONE CEMENT LOD ZIMMER BIOMET, INC. N/A 84374539

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R