BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA ALL POLY PATELLA PLY 32MM

    MDR report key: 7645900 · Received June 28, 2018

    Report

    Report Number
    0002648920-2018-00515
    Event Type
    Injury
    Date Received
    June 28, 2018
    Date of Event
    November 9, 2017
    Report Date
    November 5, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    MBH
    PMA / PMN Number
    PK172524
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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

    (B)(4). PERSONA FEMORAL CR: CATALOG#: 42-5026-064-02, LOT#: 62830391; PERSONA ALL POLY PATELLA: CATALOG#: 42-5400-000-32, LOT#: 62816540; PERSONA TIBIAL STEM: CATALOG#: 42-5320-071-02, LOT#: 63078072; PERSONA ARTICULAR SURFACE: CATALOG#: 42-5220-005-11, LOT#: 62559453. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS 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: 0001822565-2017-07445; 0002648920-2018-00516; 0001822565-2017-07448. 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. MAUDE: MW5072178.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MW5070268-3 IF ANY INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE PROCEDURE. PAIN OCCURRED CONSTANTLY SINCE THE DAY AFTER SURGERY. PATIENT RETURNED TO PHYSICIAN SEVERAL TIMES TO FIND CAUSE OF PAIN. IT WAS REPORTED THAT THE PATIENT HAD FALLEN DUE TO THE KNEE GIVING OUT. SUBSEQUENTLY, THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN, SUBSIDENCE AND INSTABILITY.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT PATIENT EXPERIENCED INSTABILITY, FREQUENT FALLS, PAIN, SWELLING, SKIN DISCOLORATION, BURNING SENSATION, INABILITY TO WALK 100 YARDS, DIFFICULTY CLIMBING STEPS, POOR GAIT, FEELS AND HEARS A POPPING SOUND COMING FROM KNEE, INFLAMMATION, BRUISING, DIFFICULTY SLEEPING, AND FLUID BUILDUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488036 PERSONA ALL POLY PATELLA PLY 32MM PROSTHESIS, KNEE MBH ZIMMER MANUFACTURING B.V. N/A 62816540

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R