BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM

    MDR report key: 6711087 · Received July 13, 2017

    Report

    Report Number
    0001825034-2017-04920
    Event Type
    Injury
    Date Received
    July 13, 2017
    Report Date
    November 15, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK043547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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: REDUCED SIZE ONCOLOGY SALVAGE SYSTEM, CAT#: 161094 LOT#: 676240; RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM), CAT#: 161036 LOT#: 593870; REDUCED SIZE ONCOLOGY SALVAGE SYSTEM, CAT#: 161035 LOT#: 659200; ONCOLOGY SALVAGE SYSTEM, CAT#: 150478 LOT#: 437100; ORTHOPEDIC SALVAGE SYSTEM- OSS, CAT#: 150493 LOT#: 409660; ONCOLOGY SALVAGE SYSTEM, CAT#: 150476 LOT#: 596510; REDUCED SIZE ONCOLOGY SALVAGE SYSTEM, CAT#: 161034 LOT#: 644580; COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM, CAT#: 178526 LOT#: 116460; COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM, CAT#: 178402 LOT#: 118150; COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM, CAT#: 178512 LOT#: 964120; COMPRESS ANTI-ROTATION SPINDLES, CAT#: 178354 LOT#: 913390. 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: 0001825034-2017-04920, 0001825034-2017-04922, 0001825034-2017-04923, 0001825034-2017-04924, 0001825034-2017-04925, 0001825034-2017-04926, 0001825034-2017-04927, 0001825034-2017-04928, 0001825034-2017-04929, 0001825034-2017-04930, 0001825034-2017-04931, 0001825034-2017-04932.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE SYSTEM PROCEDURE. PATIENT REPORTS CONSTANT ACHINESS OF THE LEG. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT THREE PROCEDURES TO LENGTHEN IMPLANT SIZE BASED ON THE PATIENT'S GROWTH OF LEG BONES. IT WAS ALSO REPORTED THAT THE PATIENT IS EXPERIENCING A CONSTANT STATE OF ACHINESS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493316 COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS 894830

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other