BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM FEMORAL STEM

    MDR report key: 6764914 · Received August 3, 2017

    Report

    Report Number
    0001825034-2017-05827
    Event Type
    Injury
    Date Received
    August 3, 2017
    Date of Event
    July 1, 2009
    Report Date
    August 3, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PNI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM FEMORAL. UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM BEARING. UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM TIBIAL TRAY. UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM ASSEMBLY. UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM FEMORAL STEM. UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM TIBIAL STEM. CUSTOMER HAS NOT INDICATED IF THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-05823/05824/05825/05826/05827/05828. NATHAN, G. F., MD, YASKO, A. W., MD, OATES, S. D., MD, LEWIS, V. O., MD, CANNON, C. P., MD, & LIN, P. P., MD. (2009). ALLOGRAFT-PROSTHETIC COMPOSITE RECONSTRUCTION OF THE PROXIMAL PART OF THE TIBIA. THE JOURNAL OF BONE AND JOINT SURGERY, INCORPORATED, 91(7), 1646-1656. DOI:10.2106/JBJS.G.01542. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE THE STUDY REPORTED 2 CASES TRANSIENT PERONEAL NERVE PALSIES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544196 UNKNOWN ORTHOPAEDIC SALVAGE SYSTEM FEMORAL STEM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other