BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCOLOGY SALVAGE SYSTEM RS NON-MODULAR SHORT TIBIAL BASE 59MM

    MDR report key: 6614971 · Received June 6, 2017

    Report

    Report Number
    0001825034-2017-03650
    Event Type
    Injury
    Date Received
    June 6, 2017
    Date of Event
    January 9, 2012
    Report Date
    September 11, 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
    NV, 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. 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND ASSOCIATED RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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

    REFERENCE CMP-(B)(4). CONCOMITANT PRODUCT: MEDICAL DEVICE-OSS POROUS COATED IM STEM 10.5 X 90MM, ITEM # 150381, LOT # 133790. OSS RS LS TIBIAL BEARING 12MM, ITEM # 161094, LOT # 240990. OSS RS RESURFACING FEMORAL LEFT 3CM , ITEM # 161006, LOT # 554420. OSS LOCKING PIN, ITEM # 150478, LOT # 559280. OSS TIBIAL BUSHING, ITEM # 150476, LOT # 931350. OSS REINFORCED YOKE, ITEM # 150493, LOT # 478850. OSS RS AXLE, ITEM # 161035, LOT # 876780. OSS RS FEMORAL BUSHINGS SET/2, ITEM # 161034, LOT # 558760. BIOMET SERIES STANDARD A PATELLA 28X8 MM, ITEM # 184762, LOT # 580230. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION DUE TO THE LOCATION OF THE DEVICE IS FOUND TO BE 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 REPORTS: 0001825034-2017-03647, 0001825034-2017-03648, 0001825034-2017-03649, 0001825034-2017-03651, 0001825034-2017-03652, 0001825034-2017-03654, 0001825034-2017-03656 AND 0001825034-2017-03657.

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING AN INITIAL LEFT KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASON. 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
    395725 ONCOLOGY SALVAGE SYSTEM RS NON-MODULAR SHORT TIBIAL BASE 59MM PROSTHESIS, KNEE KRO BIOMET ORTHOPEDICS 921570

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10