BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIM POP-TOP TIBIAL COMPONENT WITH CRUCIATE RETAINING TIBIAL BEARING 67MM

    MDR report key: 8469807 · Received April 1, 2019

    Report

    Report Number
    0001825034-2019-01513
    Event Type
    Injury
    Date Received
    April 1, 2019
    Date of Event
    March 12, 2019
    Report Date
    August 22, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K984623
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT SAMPLE WAS EVALUATED THROUGH PHOTOGRAPHIC INSPECTION, WHICH IDENTIFIED EXCESSIVE WEAR AND SEVERE DAMAGE TO ONE OF THE CONDYLES. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT DEVICES - MAXIM INTERLOK PRIMARY FEMORAL COMPONENT 65 RIGHT, CATALOG #: 140012, LOT #: 182770, BIOMET ARCOM 3 PEG PATELLA 34MM: CATALOG #: 11-150842, LOT #: 157010.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES - UNKNOWN MAXIM TIBIAL COMPONENT ,CATALOG # NI, LOT #: NI; UNKNOWN MAXIM FEMORAL COMPONENT, CATALOG #: NI, LOT #: NI. THE COMPLAINANT HAS NOT INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AFTER IT IS EXPLANTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION OF THE TIBIAL BEARING TO ADDRESS PAIN AND INSTABILITY APPROXIMATELY SIXTEEN (16) YEARS POST-OPERATIVELY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS SCHEDULED TO UNDERGO A KNEE ARTHROPLASTY REVISION OF THE TIBIAL BEARING TO ADDRESS UNKNOWN COMPLICATIONS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261865 MAXIM POP-TOP TIBIAL COMPONENT WITH CRUCIATE RETAINING TIBIAL BEARING 67MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 433860

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R