BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST PRC TIB PLT SIZE 4

    MDR report key: 7755889 · Received August 7, 2018

    Report

    Report Number
    0002648920-2018-00625
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    March 10, 2011
    Report Date
    July 1, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    PK933785
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTED: REMOVE HOSPITALIZATION AS IT WAS INCORRECTLY REPORTED INITIALLY. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE PATIENT HAS A COMPLICATION OF DELAYED WOUND HEALING. ALSO, IT WAS NOTED FROM THE MEDICAL RECORD THAT THE PATIENT TOOK SHOWER AND A SMALL STEADY STREAM OF BLOODY FLUID DRAINED FROM THE OPEN DISTAL 1/2CM OF THE INCISION. NO INFECTION NOTED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ARTICULAR SURFACE WITH LOCKING SCREW "SIZE STRIPED YELLOW/E F 20 MM HEIGHT", CAT: 00599403220, LOT: 61250709; PALACOS RG 1X40 SINGLE, CAT: 00-1113-140-01, LOT: 71274252; PALACOS RG 1X40 SINGLE, CAT: 00-1113-140-01, LOT: 71264251; PALACOS RG 1X40 SINGLE, CAT: 00-1113-140-01, LOT: 71274252; NG TRAB METAL AUG BLK POST SIZE E 5MM, CAT: 00-5490-035-01, LOT: 61426737; NG TRAB METAL AUG BLK POST SIZE E 5MM, CAT: 00-5490-035-01, LOT: 60824249; NEXGEN TRAB METAL AUG BLK DIS SIZE E 5MM, CAT: 00-5490-035-10, LOT: 61497567; NEXGEN TRAB METAL AUG BLK DIS SIZE E 5MM, CAT: 00-5490-035-10, LOT: 61497550; STEM IMPLANT 12MMDX145MM, CAT: 00-5988-010-12, LOT: 60976277; STEM IMPLANT 15MMDX145MM, CAT: 00-5988-010-15, LOT: 61171676; LCCK FEM IMPLANT SZ E-R, CAT: 00-5994-015-92, LOT: 61479175. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT 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. 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'S WOUND OPENED AND A SINGLE STITCH WAS PLACED IN THE WOUND. THERE WAS NO EVIDENCE OF INFECTION, SMALL FLUID COLLECTION AT THE ANTERIOR MEDIAL ASPECT OF THE RIGHT TIBIA NOTED, CONSISTENT WITH SMALL SEROMA OR HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600541 ST PRC TIB PLT SIZE 4 PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. 61554377

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R