BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALACOS R+G BONE CEMENT

    MDR report key: 1150043 · Received August 29, 2008

    Report

    Report Number
    1822565-2008-00561
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 16, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    LOD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BONE CEMENT IS MANUFACTURED AT HERAEUS-KULZER AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS. EVALUATION SUMMARY: THERE WAS NO BATCH NUMBER PROVIDED. THEREFORE UNABLE TO PROVIDE MANUFACTURING DATE AND EXPIRATION DATE AND NO FURTHER EVALUATION ABOUT A PARTICULAR BATCH CAN BE PERFORMED. CAUSE CAN NOT BE DEFINITIVELY DETERMINED. EVALUATION: NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFORMATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PROSTHESIS WAS IMPLANTED WITH PALACOS R+G BONE CEMENT IN 2008. AFTER APPROXIMATELY 16 MINUTES OF CEMENT SETUP TIME, THE HIP WAS REDUCED AND PUT THROUGH TRAIL RANGE OF MOTION. HIP WAS THEN DISLOCATED AND BIPOLAR COMPONENT IMPACTED AND HIP REDUCED AGAIN. SURGEON COULD NOT REDUCE HIP BECAUSE OF SOFT TISSUE IMPINGEMENT AND WANTED TO DISENGAGE THE MORSE TAPER OF THE BIPOLAR TO REMOVE IT. HE USED A BONE AND TAPPED ON THE 26 MM HEAD TO DISENGAGE THE BIPOLAR AND THE LDFX STEM POPPED RIGHT OUT OF THE FEMUR. SURGEON DID NOT THINK THAT THE CEMENT ADHERED TO THE STEM CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALACOS R+G BONE CEMENT BONE CEMENT LOD ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK