BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURAL-KNEE II STEMMED TIBIAL BASEPLATE

    MDR report key: 2172622 · Received July 20, 2011

    Report

    Report Number
    1822565-2011-01670
    Event Type
    Injury
    Date Received
    July 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE SUCH AS BONE QUALITY, HEIGHT/WEIGHT, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT) ARE UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL-KNEE II STEMMED TIBIAL BASEPLATE KNEE PROSTHESIS JWH ZIMMER, INC. 61320122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other IMPLANTED:| LOT #UNK| LOT #UNK| CATALOG #00541401502, LOT #61340325| UNKNOWN ZIMMER PATELLA, CATALOG #UNK| NEXGEN CR FLEX FEMORAL COMPONENT| UNKNOWN ZIMMER ARTICULAR SURFACE, CATALOG #UNK| IMPLANTED: