BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM TIBIAL BEARING

    MDR report key: 6819903 · Received August 25, 2017

    Report

    Report Number
    0001825034-2017-06763
    Event Type
    Injury
    Date Received
    August 25, 2017
    Date of Event
    April 12, 2017
    Report Date
    September 26, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK021260
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: ORTHOPEDIC SALVAGE SYSTEM LOCKING PIN, CAT#: 150478 LOT#: 617910. ORTHOPEDIC SALVAGE SYSTEM POROUS STEM, CAT#: 150390 LOT#: 796880. ORTHOPEDIC SALVAGE SYSTEM DIAPHYSEAL SEGMENT, CAT#: 150473 LOT#: 890180. ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE TIBIAL BUSHING, CAT#: 150476 LOT#: 889990. ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE, CAT#: 150493 LOT#: 582320. ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE FEMORAL BUSHING, CAT#: 161034 LOT#: 746770. ORTHOPEDIC SALVAGE SYSTEM AXLE, CAT#: 161035 LOT#: 274510. ORTHOPEDIC SALVAGE SYSTEM FEMORAL SEGMENT, CAT#: 161123 LOT#: 965270. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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: 0001825034-2017-06764.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601279 ORTHOPEDIC SALVAGE SYSTEM TIBIAL BEARING PROSTHESIS, KNEE KRO BIOMET ORTHOPEDICS N/A 499050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R