BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALL POLY PATELLA SIZE 1 8 MM THICKNESS

    MDR report key: 7755890 · Received August 7, 2018

    Report

    Report Number
    0001822565-2018-04220
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    March 1, 2012
    Report Date
    July 31, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    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. CONCOMITANT MEDICAL PRODUCTS: PALACOS RG 1X40 SINGLE CAT: 00-1113-140-01 LOT: 71274252 QTY: 2. 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). 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 5MMCAT: 00-5490-035-10 LOT: 61497567. NEXGEN TRAB METAL AUG BLK DIS SIZE E 5MMCAT: 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. ST PRC TIB PLT SIZE 4 CAT: 00-5980-037-02 LOT: 61554377 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. PRODUCT NOT RETURNED.

    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
    600545 ALL POLY PATELLA SIZE 1 8 MM THICKNESS KNEE, PROSTHESIS JWH ZIMMER BIOMET, INC. 61282831

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R