BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM® KNEE SYSTEM AUGMENTATION PATELLA ¿¿ SIZE: MEDIUM / THICKNESS 19MM

    MDR report key: 10007289 · Received April 28, 2020

    Report

    Report Number
    3005751028-2020-00057
    Event Type
    Injury
    Date Received
    April 28, 2020
    Date of Event
    May 19, 2011
    Report Date
    April 28, 2020
    Manufacturer
    ZIMMER TMT
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT OSS TIBIAL BEARING, CATALOG #: 150410, LOT #: 875680; OSS POLY TIBIAL BUSHING, CATALOG #: 150476, LOT #: 689570; OSS REINFORED YOKE, CATALOG #: 150493, LOT #: 063820; OSS POROUS IM STEM, CATALOG #: 150403, LOT #: 596730; OSS POLY FEMORAL BUSHINGS, CATALOG #: 150477, LOT #: 745350; OSS PROXIMAL TIBIAL, CATALOG #: 150805, LOT #: 161380; OSS POLY LOCK PIN, CATALOG #: 150478, LOT #: 855320; OSS ELLIPT FEMORAL, CATALOG #: 150357, LOT #: 236000; OSS AXLE, CATALOG #: 150480, LOT #: 786840. REVIEW OF MEDICAL RECORDS SHOWS THE CKS AUGMENTATION PATELLA WAS IMPLANTED WITH AN INCOMPATIBLE HINGED KNEE. REVIEW OF THE DEVICE HISTORY RECORD(S) FOR IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE INCOMPATIBILITY BETWEEN CKS AUGMENTATION PATELLA AND THE BIOMET HINGED KNEE MAY BE A FACTOR CONTRIBUTING TO THE PATIENT¿S ONGOING PAIN, HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS EXPERIENCING PAIN AFTER UNDERGOING A PROCEDURE TO RESURFACE THE NATIVE PATELLA POST TOTAL KNEE ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470084 CONTINUUM® KNEE SYSTEM AUGMENTATION PATELLA ¿¿ SIZE: MEDIUM / THICKNESS 19MM PROSTHESIS, KNEE JWH ZIMMER TMT N/A 61513529

    Patients

    Seq Age Sex Outcome Treatment
    1 Other