BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEMMED TIBIAL COMPONENT PRECOAT

    MDR report key: 8813141 · Received July 22, 2019

    Report

    Report Number
    0002648920-2019-00533
    Event Type
    Injury
    Date Received
    July 22, 2019
    Date of Event
    March 1, 2012
    Report Date
    July 31, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JWH
    PMA / PMN Number
    K933785
    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. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL WHICH INDICATES THAT ON (B)(6) 2011, 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. ON (B)(6) 2012, THE PATIENT EXPERIENCED PAIN ABOVE THE PATELLA AND THE QUAD TENDONS ABOVE THE INCISIONS. ALSO, EXPERIENCED PAINFUL SOFT TISSUE MASS OVER THE ANTERIOR RIGHT KNEE. SO THE PATIENT WAS TREATED WITH STEROID INJECTION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND 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.

    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: ALL POLY PATELLA SIZE 1 8 MM THICKNESS, CAT: 00542000801, LOT: 61282831. 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. PALACOS RG 1X40 SINGLE, CAT: 00-1113-140-01, LOT: 71264251. 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 12 MMD X 145 MM, 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. ST PRC TIB PLT SIZE 4, CAT: 00-5980-037-02, LOT: 61554377. 25ML, CAT: 8400-0311, LOT: 0111259111. 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 HAD PAIN JUST ABOVE HER PATELLA ON HER QUAD TENDON RIGHT BELOW THE INCISION. THE PATIENT HAD SLIPPED AND FELL ONE WEEK PRIOR TO OFFICE VISIT. A STEROID INJECTION WAS GIVEN DUE TO ONGOING AND ABNORMAL BURSITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608251 STEMMED TIBIAL COMPONENT PRECOAT PROSTHESIS, KNEE JWH ZIMMER MANUFACTURING B.V. 61554377

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R