BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC SALVAGE SYSTEM AXLE

    MDR report key: 7026018 · Received November 13, 2017

    Report

    Report Number
    0001825034-2017-10061
    Event Type
    Injury
    Date Received
    November 13, 2017
    Date of Event
    February 8, 2017
    Report Date
    December 7, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: ORTHOPEDIC SALVAGE SYSTEM TIBIAL BASEPLATE, CAT#: 150424 LOT#: 974950. ORTHOPEDIC SALVAGE SYSTEM RESURFACING FEMORAL, CAT#: 150352 LOT#: 941070. ORTHOPEDIC SALVAGE SYSTEM STEM, CAT#: 150364 LOT#: 303240. ORTHOPEDIC SALVAGE SYSTEM STEM, CAT#: 150372 LOT#: 548910. ORTHOPEDIC SALVAGE SYSTEM POLYETHYLENE BEARING, CAT#: 150413 LOT#: 671750. ORTHOPEDIC SALVAGE SYSTEM TIBIAL BUSHING, CAT#: 150476 LOT#: 850530. ORTHOPEDIC SALVAGE SYSTEM FEMORAL BUSHING, CAT#: 150477 LOT#: 610600. ORTHOPEDIC SALVAGE SYSTEM REINFORCED YOKE, CAT#: 150493 LOT#: 226980. ORTHOPEDIC SALVAGE SYSTEM LOCKING PIN, CAT#: 150478 LOT#: 744550. OPTIVAC VACUUM MIXING SYSTEM, CAT#: 417200 LOT#: 0000962085. COBALT BONE CEMENT, CAT#: 402439 LOT#: 897490. COBALT BONE CEMENT, CAT#: 402439 LOT#: 624190. FLAT FAN BLADE, CAT#: 506119 LOT#: 926199. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS 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: 0001825034-2017-10053, 0001825034-2017-10054, 0001825034-2017-10055, 0001825034-2017-10056, 0001825034-2017-10057, 0001825034-2017-10058, 0001825034-2017-10059, 0001825034-2017-10060, 0001825034-2017-10062.

    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
    804186 ORTHOPEDIC SALVAGE SYSTEM AXLE PROSTHESIS, KNEE JDI ZIMMER BIOMET, INC. N/A 315210 

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R