BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED

    MDR report key: 6653936 · Received June 20, 2017

    Report

    Report Number
    0001822565-2017-04250
    Event Type
    Injury
    Date Received
    June 20, 2017
    Date of Event
    June 4, 2009
    Report Date
    December 22, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    MEH
    PMA / PMN Number
    PK161830
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS ABLE TO BE CONFIRMED VIA THE OPERATIVE REPORT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: METASUL® DUROM®, COMPONENT FOR ACETABULUM, UNCEMENTED, 54/ø 48, CODE N/ PN 0100214054/ LN 2307987, METASUL® LDH®, HEAD, 48, CODE N, TAPER 18/20/ PN 0100181480/ LN 2301566, METASUL® LDH®, HEAD ADAPTER, S, -4, TAPER 12/14-18/20/ PN 0100185145/ LN 2310327. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO THE PRODUCT LOCATION BEING UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT THAT WAS FILED BY (B)(4): 0009613350-2017-00494.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED IN REVISION OPERATIVE NOTES STATE THAT THE PATIENT WAS EXPERIENCING PSEUDOTUMOR OCCUPYING THE ENTIRE POSTERIOR INTERVAL BEHIND THE HIP JOINT. THE SCIATIC NERVE WAS ENCASED WITHIN THE TUMOR AND A 15-20% LACERATION WAS MADE THROUGH THE SCIATIC NERVE. IN ADDITION TO THE PSEUDOTUMOR A LOT OF METALLOSIS WAS NOTED AT THE JUNCTION BETWEEN THE FEMORAL STEM AND THE FEMORAL HEAD. THE CUP AND HEAD WERE REMOVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT RIGHT HIP REVISION DUE TO CORROSION IN THE FEMORAL HEAD APPROXIMATELY THREE YEARS POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434737 FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PROSTHESIS, HIP MEH ZIMMER, INC. N/A 60313025

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R