BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REDUCED SIZE ONCOLOGY SALVAGE SYSTEM - 18MM LS TIBIAL BEARING

    MDR report key: 6549617 · Received May 5, 2017

    Report

    Report Number
    0001825034-2017-03108
    Event Type
    Injury
    Date Received
    May 5, 2017
    Date of Event
    July 19, 2017
    Report Date
    August 29, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK021260
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. FROM THE INFORMATION AVAILABLE, IT IS NOTED THAT THE PATIENT DOESN'T HAVE AN EXTENSOR MECHANISM WHICH LEADS TO DEEP FLEXION AND DISASSOCIATION OF THE YOKE. THE ROOT CAUSE FOR THE REPORTED ISSUE IS DETERMINED AS PATIENT'S ANATOMY (CONDITION). 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. CONCOMITANT PRODUCTS¿ OSS TIBIAL YOKE CATALOG 150493 LOT 582320; OSS POLY TIBIAL BUSHING CATALOG 150476 LOT 889990; UNKNOWN OSS TIBIAL BASEPLATE; OSS POLY LOCK PIN CATALOG 150478 LOT 710100; OSS 21CM DIAPHYSEAL SEGMENT CATALOG 150473 LOT 890180; OSS RS POLY FEMORAL BUSHINGS CATALOG 161034 LOT 746770; OSS RS AXLE CATALOG 161035 LOT 274510; OSS RS 8.5CM SEG FMRL RIGHT CATALOG 161123 LOT 965270. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 1825034-2017-03108, 1825034-2017-05298, 1825034-2017-05258, 1825034-2017-05259, 1825034-2017-05299, 1825034-2017-05300, 1825034-2017-05301, 1825034-2017-05302, 1825034-2017-05303.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS NOT INDICATED THAT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY THREE MONTHS POST IMPLANTATION DUE TO QUADRICEPS DEFICIENCY. THE PATIENT WAS ALSO REPORTED AS EXPERIENCING DISLOCATION AND DISASSOCIATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN INDICATED FOR REVISION DUE TO QUADRICEPS DEFICIENCY. NO REVISION HAS BEEN REPORTED TO DATE. 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
    330085 REDUCED SIZE ONCOLOGY SALVAGE SYSTEM - 18MM LS TIBIAL BEARING PROSTHESIS, KNEE KRO BIOMET ORTHOPEDICS 913460

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R