BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA ASF CR 11MM VE R 3-11 EF

    MDR report key: 7645895 · Received June 28, 2018

    Report

    Report Number
    0001822565-2018-03483
    Event Type
    Injury
    Date Received
    June 28, 2018
    Report Date
    June 21, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    PMA / PMN Number
    PK172524
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED WITH MEDICAL RECORDS RECEIVED. REVISION OPERATIVE NOTES PROVIDED STATE THAT THE SURGEON INDICATES THAT THE PATIENT HAD SUPERFICIAL INFECTION IN HIS KNEE IN PREVIOUS POST OPERATIVE COURSE. THERE WAS SOME CONCERN THAT THE PATIENT MIGHT HAVE SUBCLINICAL INFECTION WHICH MAY BE CAUSING THE CHRONIC PAIN. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE CANNOT 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). 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: 0001822565-2018-03482, 0002648920-2018-00517, 0002648920-2018-00518, 0001822565-2018-03483. 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.PDF].

    Additional Manufacturer Narrative · 1

    CMP-(B)(4) THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: (B)(4) 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. - ATTACHMENT: [CMP-(B)(4) ADDITIONAL INFORMATION ((B)(6)2018).PDF]

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED SUPERFICIAL INFECTION AND POSSIBLY A CHRONIC INFECTION OF THE KNEE DUE TO ELEVATED INFLAMMATORY MARKERS. IT IS UNKNOWN WHEN THE INFECTION OCCURRED OR IF ANY PREVIOUS TREATMENT WAS GIVEN.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PHYSICIAN STATED THERE WAS NO EVIDENCE OF INFECTION. HOWEVER, THE PATIENT IS REACHING OUT TO GET A SECOND OPINION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488033 PERSONA ASF CR 11MM VE R 3-11 EF PROSTHESIS, KNEE MBH ZIMMER BIOMET, INC. N/A 62559453

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R